Atlas FDA

FOZ

506 FDA 510(k) clearances · Product code

101 daysmedian time to decision
291 days90th percentile
506clearances measured

FDA profile

Official device name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5200
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 4,674 · 2022: 4,133 · 2023: 4,430 · 2024: 4,774 · 2025: 5,188 · 2026: 2,730
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
ClearSafe Closed System (K261041)MedSource Labs, LLC2026-07-10
MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV Catheter (K260539)MedSource Labs, LLC2026-07-09
Introcan Safety® Deep Access XL IV Catheter (K253235)B.Braun Medical, Inc.2026-05-15
BD Insyte™ IV Catheter (K252137)Becton Dickinson Infusion Therapy Systems, Inc.2026-04-02
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) (K252513)Poly Medicure Limited2026-04-01
SURFLO Hybria Closed System Safety IV Catheter (K252398)Terumo Medical Products (Hangzhou) Co., Ltd.2025-12-17
Polyshield Safety IV Catheters (K252677)Poly Medicure Limited2025-11-05
BD Saf-T-Intima™ Subcutaneous Catheter System (K251422)Becton Dickinson Infusion Therapy Systems, Inc.2025-10-08
BD Nexiva™ Closed IV Catheter System (K243403)Becton Dickinson Infusion Therapy Systems, Inc.2025-07-25
BD Cathena™ Safety IV Catheter (K251155)Becton Dickinson Infusion Therapy Systems, Inc.2025-07-11
BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (K251654)Becton Dickinson Infusion Therapy Systems, Inc.2025-06-27
BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K250682)Becton Dickinson Infusion Therapy Systems, Inc.2025-06-03
Ruby Intravascular Catheter (K243105)Venocare, Inc.2025-05-16
OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (K250292)Skydance Vascular, Inc.2025-05-02
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104) (K244059)Access Vascular, Inc.2025-03-27
Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) (K243599)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2025-03-14
Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822) (K242281)Arrow International, LLC (A subsidiary of Teleflex, Inc.)2024-12-20
SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter (K241115)Spectrum Vascular2024-11-27
PowerGlide Pro™ Midline Catheter (K240359)Becton, Dickinson and Company (Bard Access Systems, Inc.)2024-07-29
Introcan Safety® 2 IV Catheter (K241845)B.Braun Medical, Inc.2024-07-26
AccuCath Ace™ Intravascular Catheter (K233106)Bard Access Systems, Inc. (C.R. Bard, Inc.)2024-04-19
Nouvo Safety Set (K232234)Poly Medicure Limited2024-03-15
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K233529)Becton Dickinson Infusion Therapy Systems, Inc.2023-12-01
Nexiva™ Closed IV Catheter System with NearPort™ IV Access (K231239)Becton Dickinson Infusion Therapy Systems, Inc.2023-09-22
Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (K231401)Poly Medicure Limited2023-09-21
The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter (K223788)Medsource International, LLC2023-09-15
OSPREY Closed IV Catheter System (OspreyV2) (K231626)Skydance Vascular, Inc.2023-08-31
Mais Central Venous Catheter (K221827)Saudi Mais Co. For Medical Products2023-06-23
Polyguard and Polyshield Safety IV Catheters (K230616)Poly Medicure Limited2023-05-05
OSPREY PERIPHERAL IV Catheter System (K223018)Skydance Vascular, Inc.2023-04-14
Cook® Spectrum® 2 MRC Central Venous Catheter (K223648)Cook Advanced Technologies2023-02-03
HydroMID 4F Single Lumen Midline Catheter (K220772)Access Vascular, Inc.2022-12-07
MagiCath II (K210929)Woo Young Medical Co., Ltd.2022-09-13
Leaderflex Mini and Leaderflex Nano (K212370)Vygon USA2022-08-29
Introcan Safety 2 IV Catheter (K220756)B.Braun Medical, Inc.2022-06-23
Introcan Safety IV Catheter (K220626)B.Braun Medical, Inc.2022-05-14
BD Cathena Safety IV Catheter (K220584)Becton Dickinson Infusion Therapy Systems, Inc.2022-03-31
Pluski Safe 1 Safety IV Catheter (K210037)Mediplus (India) Limited2022-03-25
B. Braun Introcan Safety 2 IV Catheter (K213664)B.Braun Medical, Inc.2022-02-11
Introcan Safety 3 Closed IV Catheter (K213085)B.Braun Medical, Inc.2021-10-25
Disposable IV catheter (K202060)Shinva Ande Healthcare Apparatus Co., Ltd.2021-07-23
BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System (K200891)Becton, Dickinson and Company2021-06-02
HydroMID (K203069)Access Vascular, Inc.2021-02-08
BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter (K201075)Becton, Dickinson and Company2020-12-18
ACENT™ Central Venous Catheter (K193158)Global Medikit Limited2020-11-24
BD Cathena Safety IV Catheter (K201717)Becton Dickinson Infusion Therapy Systems, Inc.2020-09-22
Deltaven Fast Flash Closed I.V. Catheter Systems (K200373)Delta Med Spa2020-08-26
MedSource CathMED IV Catheter (K193278)Medsource Labs2020-08-07
MF SAFECATH (K192230)Medifirst Co., Ltd.2020-04-23
BD Centro Vena Acute Central Line (7 French Dual Lumen) (K200266)Bard Access Systems, Inc. (Bard Has Joined Bd)2020-04-07
Introcan Safety 2 IV Catheter 18-24 gauge (K192676)B.Braun Medical, Inc.2020-04-01
Health Line CT Midline Catheter (K200263)Health Line International Corporation2020-03-12
BD Cathena (TM) Safety IV Catheter (K192493)Becton Dickinson Infusion Therapy Systems, Inc.2020-01-24
Health Line CT CVC (K192533)Health Line International Corporation2019-12-10
BD Acute Central Line (K190855)Bard Access Systems, Inc. (Bard Has Joined Bd)2019-11-01
Supercath 5 (K190001)Togo Medikit Co., Ltd.2019-09-20
AccuCath Ace Intravascular Catheter (K191232)C.R. Bard, Inc.2019-09-18
Cook Unimpregnated Central Venous Catheter (K182252)Cook Incorporated2019-05-17
BD Nexiva Closed IV Catheter System (K183399)Becton Dickinson Infusion Therapy Systems, Inc.2019-03-20
Introcan Safety 3 Closed IV Catheter (K182870)B.Braun Medical, Inc.2019-03-07
Merit RadialFlo Arterial Catheter (K182538)Merit Medical Singapore Pte. , Ltd.2019-01-16
SUPERCATH 5 (26G) (K172496)Togo Medikit Co., Ltd.2018-03-23
Deltaven XiV Max, Deltaven XiV Max FF (K171530)Delta Med Spa2017-12-21
BD Nexiva Diffusics Closed IV Catheter Systems (K173354)Becton Dickinson Infusion Therapy Systems, Inc.2017-12-15
BD Cathena Safety IV Catheter (K172506)Becton, Dickinson and Company2017-09-17
BD Intima II PLUS Closed IV Catheter System (K172204)Becton, Dickinson and Company2017-08-17
Introcan Safety 3 Closed IV Catheter (K163358)B.Braun Melsungen AG2017-04-28
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector (K170336)Becton, Dickinson and Company2017-03-10
Nipro SafeTouch IV Catheter (K161681)Nipro Medical Corporation2017-03-08
BD Nexiva Diffusics Closed IV Catheter System (K170283)Becton, Dickinson and Company2017-02-28
Arrow Endurance Extended Dwell Peripheral Catheter System (K163513)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2017-02-24
AccuCath Intravascular Catheter (K162894)C.R. Bard, Inc.2016-11-15
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter (K161779)Medsource International, LLC2016-11-03
PowerGlide Pro Midline Catheter (K162377)C.R. Bard, Inc.2016-09-22
BioFlo Midline Catheter (K161866)Navilyst Medical, Inc.2016-09-08
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems (K161777)Becton Dickinson Infusion Therapy Systems, Inc.2016-08-29
SUPERCATH 6 (K160592)Togo Medikit Co., Ltd.2016-08-12
ViaValve Safety I.V. Catheter (K160235)Smiths Medical Asd, Inc.2016-06-30
PowerGlide Pro Midline Catheter (K153280)C.R. Bard, Inc.2016-06-02
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System (K160374)Tangent Medical Technologies, Inc.2016-03-11
AccuCath Intravascular Catheter (K153298)C.R. Bard, Inc.2015-12-10
Arrow Endurance Extended Dwell Peripheral Catheter System (K152272)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2015-11-23
BD Angiocath IV Catheter, BD Insyte IV Catheter (K151698)Becton Dickinson Infusion Therapy Systems, Inc.2015-07-27
MedSource ClearSafe Safety IV Catheter (K150611)Medsource International2015-07-15
Arrow Endurance Extended Dwell Peripheral Catheter System (K151513)Arrow Internation, Inc. (Subsidiary of Teleflex Inc.)2015-07-08
I.V. Catheter (K142797)Jiangxi Sanxin Medtec Co., Ltd.2015-06-18
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology (K150109)Arrow International (A Subsidiary of Teleflex, Inc.)2015-06-05
BioFlo Midline Catheter (K150407)Navilyst Medical, Inc.2015-05-15
BD INTIMA II CLOSED IV CATHETER (K143610)Becton Dickinson Infusion Therapy Systems, Inc.2015-04-09
ACCUCATH MIDLINE CATHETER SYSTEM (K142136)Vascular Pathways, Inc.2015-01-08
NEXUS MIDLINE CT CATHETER (K140270)Health Line International Corporation2014-08-20
LEADERFLEX (K141026)Vygon2014-07-30
ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM (K140504)Vascular Pathways, Inc.2014-07-17
TERUMO SURFLO I.V. CATHETER (K133280)Terumo (Philippines) Corporation2014-06-12
SURFLASH SAFETY I.V. CATHETER (K141138)Kofu Factory of Terumo Corp.2014-05-30
SUPERCATH5 (K140419)Togo Medikit Co., Ltd.2014-05-12
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE (K140136)Nipro Medical Corporation2014-02-14
MEDSOURCE IV SAFETY CATHETER (K131555)Medsource International, LLC2014-01-31
POWERGLIDE MIDLINE CATHETER (K133856)C.R. Bard, Inc.2014-01-16
SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER (K132153)Nipro Medical Corporation2013-12-05
Next →

Track FOZ automatically

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