Atlas FDA

OMP

214 FDA 510(k) clearances · Product code

172 daysmedian time to decision
373 days90th percentile
214clearances measured

FDA profile

Official device name
Negative Pressure Wound Therapy Powered Suction Pump
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Medical specialty
General, Plastic Surgery
FDA definition
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Adverse events (MAUDE)
2021: 1,422 · 2022: 258 · 2023: 143 · 2024: 135 · 2025: 143 · 2026: 53
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ConvaVAC™ Negative Pressure Wound Therapy System (K253263)Convatec Limited, Gdc Building2026-06-24
CURASYS 2 (EMDN0003) (K253199)CG Bio Co., Ltd.2026-06-23
RENASYS EDGE (66803126) (K260646)Smith & Nephew Medical, Ltd.2026-05-27
Nisus NPWT Canister 500-mL (CPC-500) (K261291)Cork Medical2026-05-21
Wound Geni NPWT System (K254019)Bechtel Medical, Inc.2026-05-04
Genadyne ASTRA NPWT (K253429)Genadyne Biotechnologies, Inc.2026-03-12
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory (K250586)Deroyal Industries, Inc.2025-11-21
extriCARE® 1000 Negative Pressure Wound Therapy System (K251646)Alleva Medical Devices2025-10-03
RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (K251826)Smith & Nephew Medical, Ltd.2025-09-11
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (K243187)Cork Medical2025-06-27
RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port (K243576)Smith & Nephew Medical, Ltd.2025-02-18
Genadyne DUO NPWT (K233614)Genadyne Biotechnologies, Inc.2024-12-23
VERSA Negative Pressure Wound Therapy System (VCMPP-100) (K241061)Cork Medical2024-08-21
Negative Pressure Wound Therapy Device (V-Move, V-Grand) (K241023)Med Way, Inc.2024-08-19
NEXA™ NPWT System (K241515)Nexa Medical Limited2024-07-26
Renasys Edge (K231939)Smith & Nephew Medical, Ltd.2024-05-24
3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) (K241134)Kci USA, Inc.2024-05-23
Prospera Spectruum Negative Pressure Wound Therapy System (K230233)Deroyal Industries, Inc.2024-04-18
Carilex VT¿200-i NX (K231646)Carilex Medical, Inc.2024-04-17
PREVENT Kit (K232379)Clear Choice Therapeutics2024-02-05
Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) (K230677)Cork Medical2023-12-06
Invia® Integrated Dressing (K223388)Medela AG2023-07-07
Genadyne Hybrid Foam Dressings (K221888)Genadyne Biotechnologies, Inc.2023-06-12
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit (K221585)3M Healthcare Business Group2023-03-23
3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) (K222859)3M2023-03-23
extriCARE 1000 Negative Pressure Wound Therapy System (K213906)Alleva Medical, Ltd.2023-03-08
RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large (K213853)Smith and Nephew Medical Limited2023-02-10
extriCARE® 3000 Negative Wound Pressure Therapy System (K221223)Alleva Medical Devices2023-02-09
UNO Negative Pressure Wound Therapy System (K221891)Genadyne Biotechnologies, Inc.2022-12-14
Renasys Edge (66803126) (K223041)Smith & Nephew Medical Limited2022-11-22
PWD Negative Pressure Wound Therapy System (K212359)Applied Tissue Technologies, LLC2022-09-21
Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112)Medela AG2022-07-26
Dermatac Drape (K220560)3M2022-07-14
Prevena Restor Adapti-Form Dressing (K220660)3M Healthcare Business Group2022-07-01
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (K210107)Genadyne Biotechnologies, Inc.2022-06-01
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (K211571)Zhejiang Longterm Medical Technology Co., Ltd.2022-05-31
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing (K202783)Smith & Nephew Medical Limited2022-01-14
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs (K211318)Smith Nephew Medical Limited2022-01-05
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System (K202898)Lightstone Medical Products (Ningbo) Co, Ltd.2021-12-30
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) (K211521)3M Healthcare Business Group2021-12-20
Theia NPWT Foam Wound Dressing Kit (K211277)Clear Choice Therapeutics, Inc.2021-12-16
Innomed NPWT Silicone Foam Dressing (K202823)Zhejiang Longterm Medical Technology Co., Ltd.2021-12-15
V.A.C.ULTA Negative Pressure Wound Therapy System (K203316)Kci, A Part of 3M Health Care Business Group2021-10-27
Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac (K212320)3M Healthcare Business Group2021-09-28
Nisus Touch Negative Pressure Wound Therapy Pump (K203693)Cork Medical Products, LLC2021-08-13
Avance Solo Negative Pressure Wound Therapy (NPWT) System (K203369)Molnlycke Health Care Us, LLC2021-07-01
Kendall NPWT Incision Management Device (K202217)Cardinalhealth2021-06-04
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack (K202157)Smith & Nephew Medical Limited2020-10-30
PocketDoc™ Micro Wound Therapy System (K200223)Pensar Medical, LLC2020-10-23
Kendall NPWT Incision Management Dressing Kit (K191101)Cardinalhealth2020-07-31
ACTIV.A.C. Negative Pressure Wound Therapy System (K201571)Kci USA, Inc.2020-07-08
V.A.C. DERMATAC Drape (K200390)Kci USA, Inc.2020-05-18
UNO 30 (K190028)Genadyne Biotechnologies2020-01-15
PICO 14 Single Use Negative Pressure Wound Therapy System (K191760)Smith & Nephew Medical Limited2019-12-05
PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) (K190697)Kci USA, Inc.2019-11-22
Foryou NPWT Dressing Kit (K190119)4l Health Co., Ltd.2019-11-01
XLR8 Abdominal Wound Dressing Kit (K182722)Genadyne Biotechnologies2019-09-27
PWD Platform Wound Dressing 3” x 5” Oblong (K191460)Applied Tissue Technologies, LLC2019-07-02
Longterm NPWT Foam Dressing Kit (K182458)Zhejiang Longterm Medical Technology Co., Ltd.2019-05-23
V.A.C. DERMATAC Drape (K181505)Kci USA, Inc.2019-03-28
MiMo(TM) Negative Pressure Wound Therapy System (K181929)Baymax Research, Inc.2019-03-27
RENASYS Touch; RENASYS Y-Connector (K181822)Smith & Nephew Medical Limited2019-03-21
ACTIV.A.C. Therapy Unit (K183543)Kci USA, Inc.2019-03-20
PREVENA RESTOR(TM) Incision Management System (K181507)Kci USA, Inc.2019-02-15
Invia Abdominal Dressing Kit (K182191)Medela AG2019-02-01
PICO 7Y Single Use Negative Pressure Wound Therapy System (K182323)Smith & Nephew Medical Limited2019-01-18
Applied Tissue Technologies PWD™ Platform Wound Dressing (K182409)Applied Tissue Technologies, LLC2019-01-11
RENASYS Y-Connector; RENASYS TOUCH (K181204)Smith & Nephew Medical Limited2019-01-10
UNO Negative Pressure Wound Therapy System (K180840)Genadyne Biotechnologies, Inc.2018-11-30
Invia White Foam NPWT (K180415)Medela AG2018-11-02
AVELLE Negative Pressure Wound Therapy System (K180205)Convatec Limited2018-10-19
PICO 7 Single Use Negative Pressure Wound Therapy System (K180698)Smith & Nephew Medical Limited2018-08-21
VT - 100, VT - 200 (K173407)Carilex Medical, Inc.2018-08-09
VT Dressing Kits (K172725)Carilex Medical, Inc.2018-06-08
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System (K180855)Kci USA, Inc.2018-06-01
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad (K172145)Medela AG2018-05-09
PICO Single Use Negative Pressure Wound Therapy System (K180618)Smith & Nephew Medical Limited2018-04-20
PICO Single Use Negative Pressure Wound Therapy System (K180614)Smith & Nephew Medical Limited2018-04-06
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System (K173426)Kci USA, Inc.2018-03-09
V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit (K173447)Kci USA, Inc.2018-03-02
PICO 7 Single Use Negative Pressure Wound Therapy System (K172005)Smith & Nephew Medical Limited2018-02-02
Occlusion Detection Dressing Kit (K171499)Cardinalhealth2017-09-22
PICO Single Use Negative Pressure Wound Therapy System (K172521)Smith & Nephew Medical Limited2017-09-20
PICO Single Use Negative Pressure Wound Therapy System (K172519)Smith & Nephew Medical Limited2017-09-15
NEXA Negative Pressure Wound Therapy System (K162610)Nexa Medical , Ltd.2017-06-08
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing (K162159)Vr Medical Technologies, LLC2017-04-28
PICO Single Use Negative Pressure Wound Therapy System (K163387)Smith & Nephew Medical Limited2017-04-18
UNO Negative Pressure Wound Therapy System (K161599)Genadyne Biotechnologies, Inc.2017-04-06
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film (K170088)Medela AG2017-04-06
MyNeWT Negative Pressure Wound Therapy System (K161432)Stortford Medical, LLC2017-02-08
V.A.C.ULTA Negative Pressure Wound Therapy System (K162790)Kci USA, Inc. (Kinetic Concepts, Inc.)2017-01-26
Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set (K161418)Cardinalhealth2017-01-19
V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System (K160487)Kci USA, Inc.2016-12-09
Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply (K161128)Medela AG2016-12-01
WoundPro Negative Pressure Wound Therapy System (K150960)Pensar Medical, LLC2016-12-01
Avance Foam Dressing Kit - XL (K161935)Molnlycke Health Care Us, LLC2016-11-04
Avance Gauze Dressing Kits (K161948)Molnlycke Health Care Us, LLC2016-11-03
Avance Tubing, Avance Y-Connector, Avance ViewPad (K161797)Molnlycke Health Care Us, LLC2016-10-19
VT·One, VT·One 60days (K161410)Carilex Medical, Inc.2016-10-13
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (K161897)Kci USA, Inc. (Kinetic Concepts, Inc.)2016-10-04
Next →

Track OMP automatically

Every clearance here is in the API, with alerts when new ones post.