Atlas FDA

JOW

352 FDA 510(k) clearances · Product code

127 daysmedian time to decision
274 days90th percentile
352clearances measured

FDA profile

Official device name
Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 34 · 2022: 27 · 2023: 57 · 2024: 30 · 2025: 24 · 2026: 48
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Flexitouch® Plus Advanced Pneumatic Compression System (K253555)Tactile Medical2026-07-31
DVT Garment (K253386)Vistar Medical Supplies Co., Ltd.2026-06-25
Compression Therapy Device (LGT-2202DVT) (K250242)Guangzhou Longest Medical Technology Co., Ltd.2026-04-24
NanoPress 760A-BT (760A-BT) (K254267)Mego Afek , Ltd.2026-02-24
Bio Arterial Deluxe (IC-BAP-DX) (K250974)Bio Compression Systems, Inc.2025-12-12
Sequential Compression System (SCD600) (K250190)Shenzhen Comen Medical Instruments Co.,Ltd2025-12-08
VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr (K251466)Wellell, Inc.2025-10-28
PlasmaFlow X Compression Sleeve Device (XPF0001) (K251446)Manamed, LLC2025-09-17
PnueAira (PNCU-01) (K251086)Biotab, LLC2025-08-18
Coretech Compression System (Coretech RHB3003) (K250817)Vive Health, LLC2025-08-08
Venera 608 Deep Vein Thrombosis (DVT) Prevention System (K241096)Suzhou Minhua Medical Apparatus Supplies Co., Ltd.2025-01-15
ARTAIRA Arterial Compression Device (AACD01) (K240499)Airos Medical, Inc.2024-10-11
UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFF (K241746)United Medical Resources, LLC2024-10-04
Venowave VW5 (K232640)Thermabright2024-06-25
Therm-X (Home); Therm-X (AT) (K240125)Zenith Technical Innovations2024-06-21
Nimbl (model PD08-N1) (K234155)Tactile Medical2024-06-21
DVT Motion Pneumatic Compression Device (K232270)Koge Micro Tech Co., Ltd.2024-03-06
Lymphedema Compression (K240011)Jkh Health Co., Ltd.2024-02-23
Dayspring (K223228)Koya Medical, Inc.2024-01-04
ElastiMed SACS (K232300)Elastimed , Ltd.2023-12-22
MedHealth DVT compression Devices MHH900S/MHH900E (K231801)Medhealth Medical Limited2023-12-14
AeroDVx Arm System (K222823)Sun Scientific, Inc.2023-09-07
LEGACY® IPC (K232006)Ig Technology, Ltd.2023-08-04
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly (K230028)Cardinal Health200, LLC2023-04-03
Capiflo 5001 (K222158)K&L Distributing, Inc.2023-01-20
AIROS 6P Sequential Compression Device (K223195)Airos Medical, Inc.2022-12-09
AIROS 8P Sequential Compression Device (K223193)Airos Medical, Inc.2022-12-09
medi pneumatic compression system (pcs)-genius (Model 652) (K221654)Medi USA, LP2022-07-07
VenAir, Sequential Compression System (K213577)Apex Medical Corp.2022-06-28
CIRCUL8 Connect DVT Prevention Device (K220761)Ortho8, Inc.2022-06-03
Amputee Garment for use with Lympha Press Optimal Plus (K214053)Mego Afek AC , Ltd.2022-04-14
Veinoflow SCD (Model: LBTK-M-I 5006) (K213313)Dalian Labtek Science & Development Co., Ltd.2022-02-09
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System (K211937)Jiangsu Synecoun Medical Technology Co., Ltd.2021-11-18
Circul8 Pro (K212731)Ortho8, Inc.2021-11-15
Venen-trainer (Model: FM150, SFM90) (K203746)Shenzhen Pango Electronic Co., Ltd.2021-11-10
Dayspring Lite (K212287)Koya Medical, Inc.2021-09-21
CIRCUL8 Luxe DVT Prevention Device (K211235)Ortho8, Inc.2021-09-08
WoundExpress (K211200)Huntleigh Healthcare , Ltd.2021-09-03
PlasmaWave (K211253)Manamed, Inc.2021-05-26
Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (K210417)Bio Compression Systems, Inc.2021-05-14
Reprocessed Tri Pulse Compression Garment (K203847)Renu Medical, Inc.2021-05-07
Dayspring (K210885)Koya Medical, Inc.2021-04-23
DVT-PRO (K203353)Daesung Maref Co., Ltd.2021-04-22
SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System (K203310)Jiangsu Synecoun Medical Technology Co., Ltd.2021-04-02
DVT-4000S (K203417)Daesung Maref Co., Ltd.2021-03-28
Movement and Compressions System (the MAC System) (K203052)Recovery Force, LLC2021-03-21
Ezlymph, Ezlymph M (K193662)Eezcare Medical Corp2021-02-11
Overlapped Compression Therapy (K202839)Jkh Health Co., Ltd.2021-01-21
Flexitouch Plus System (K203178)Tactile Systems Technology, Inc. (Dba Tactile Medical)2020-12-20
DVT-2600 (K203016)Daesung Maref Co., Ltd.2020-12-05
B&J DVT Calf/Thigh Garments, Models 801/830 Series (K201532)B&J Manufacturing , Ltd.2020-09-19
B&J DVT Foot Garments, Models 820 Series (K201547)B&J Manufacturing , Ltd.2020-09-18
VariLymph 12 pro (K193476)Slk Medical GmbH2020-08-19
ManaFlow (K200353)Manamed, Inc.2020-08-06
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System (K200568)B&J Manufacturing , Ltd.2020-07-10
B&J DVT Compression Devices MHH800/MHH800SQ (K200154)B&J Manufacturing , Ltd.2020-07-08
VenaOne (K200285)Vena Group, LLC2020-07-02
Zeroveno (K192337)Dimedi Co., Ltd.2020-06-22
Koya Ripple (K193288)Koya, Inc.2020-06-16
Aria System (K200564)Inova Labs2020-04-03
Compression Therapy Device (K191856)Guangzhou Longest Science & Technology Co., Ltd.2020-03-19
Ezvena IPC, Ezvena SQS (K191937)Eezcare Medical Corp2020-01-29
AIROS 6 Sequential Compression Device (K193069)Airos Medical, Inc.2019-12-04
AIROS 8 Sequential Compression Device (K193068)Airos Medical, Inc.2019-12-04
VenaPro Vascular Therapy System (K193020)Innovamed Health, LLC2019-12-04
Plexus (K191107)Alleva Medical (D.G), Ltd.2019-08-27
Plexus SCD110 Sequential Compression Device Sleeve (K190975)Midway Medical, LLC2019-07-22
AeroDVx System (K183349)Sun Scientific, Inc.2019-07-19
Radial Medical Compression System (K190976)Radial Medical, Inc.2019-07-12
Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System (K190423)Devon Medical Products (Jiangsu), Ltd.2019-03-19
Lympha Press Optimal Plus (K182003)Mego Afek AC , Ltd.2019-02-27
Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device (K182578)Devon Medical Products (Jiangsu), Ltd.2019-02-21
medi pneumatic compression system (pcs) – brio (Model 651) (K183631)Medi USA, LP2019-01-25
Pulse Rx 2.0, Pulse Pro Rx 2.0 (K183328)NormaTec Industries, LP2018-12-21
Devon 52 Sequential Compression Device (K182150)Devon Medical Products (Jiangsu), Ltd.2018-12-18
Radial Medical Compression System (K181651)Radial Medical, Inc.2018-10-12
VascuEase IC-1200-WH (K180248)Bio Compression Systems, Inc.2018-08-07
VesoFlow Lite DVT Compression Device (K181217)Caremed Supply, Inc.2018-08-05
Venera 508 Deep Vein Thrombosis (DVT) Prevention System (K180389)Suzhou Minhua Medical Apparatus Supplies Co., Ltd.2018-06-29
AIROS 6 Sequential Compression Device (K172770)Airos Medical, Inc.2018-06-22
AIROS 8 Sequential Compression Device (K172779)Airos Medical, Inc.2018-06-22
ANGIO-PRESS LITE DVT Compression Device (K173012)Pegasus Medical Supply, Inc.2018-05-10
Flowtron DVT5 Small Calf Garment (K172103)Getinge (Suzhou) Co., Ltd.2018-03-02
Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System (K173528)Devon Medical Products (Jiangsu), Ltd.2018-02-06
Devon 51 (K172030)Devon Medical Products (Jiangsu), Ltd.2017-11-27
Phlebo Press DVT Model (K172277)Mego Afek AC , Ltd.2017-11-03
Medline Hemo-Force DVT Compression Sleeve (K170415)Medline Industries, Inc.2017-09-08
Sequential Circulator SC-2004FC-OC (K171793)Bio Compression Systems, Inc.2017-08-17
Devon 24 (K170814)Devon Medical Products (Jiangsu), Ltd.2017-07-11
Lympha Press Optimal Plus (K170658)Mego Afek AC , Ltd.2017-05-31
Flexitouch System (K170216)Tactile Systems Technology, Inc. (Dba Tactile Medical)2017-05-26
RF1400 Active Compression Wrap (K162481)Recovery Force, LLC2017-02-16
Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves (K163620)Covidien2017-01-19
Reprocessed Kendall SCD Express Foot Cuff (K163055)Covidien2016-12-23
Intermittent Pneumatic Compression system (K160180)Daesung Maref Co., Ltd.2016-11-03
Reprocessed Compression Garments (K161105)Covidien2016-08-18
ActiveCare Home (K160431)Medical Compression Systems (Dbn) , Ltd.2016-07-13
NormaTec PCD-T and PCD-B (K161346)NormaTec Industries, LP2016-06-15
Cirona 6400 (K161209)Devon Medical Products2016-05-31
Venous Assist System (K150980)Daesung Maref Co., Ltd.2016-05-12
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