Atlas FDA

FOS

34 FDA 510(k) clearances · Product code

150 daysmedian time to decision
227 days90th percentile
34clearances measured

FDA profile

Official device name
Catheter, Umbilical Artery
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5200
Medical specialty
General Hospital
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 49 · 2022: 38 · 2023: 20 · 2024: 52 · 2025: 56 · 2026: 13
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
Umbilical Vessels Catheter (K201697)Haolang Medical USA Corporation2021-05-06
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. (K130725)Covidien Lp, Formerly Registered AS Kendall2013-04-17
FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER (K120304)Footprint Medical, Inc.2012-03-01
FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (K091214)Footprint Medical2009-09-25
FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (K091213)Footprint Medical2009-09-25
NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0 (K081515)Neomed, Inc.2008-07-21
NEOMED SINGLE LUMEN UMBILICAL CATHETER (K073596)Neomed, Inc.2008-02-22
VYGON DOUBLE LUMEN UMBILICAL CATHETER (K981630)Schiff & Co.1998-10-01
NEO-CARE DUAL LUMEN UMBILICAL CATHETER (K963972)Klein-Baker Medical, Inc.1996-12-24
ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY (K954300)Sherwood Medical Co.1995-12-13
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER (K951738)Sherwood Medical Co.1995-09-29
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY (K951737)Sherwood Medical Co.1995-09-28
CENTURION UMBILICAL CATHETER (K942353)Tri-State Hospital Supply Corp.1995-08-15
IV CATHETER AND OBTURATOR (K941429)Becton Dickinson Vascular Access, Inc.1995-01-04
SENTRY INSERTION TRAY (K942827)Sentry Medical Products, Inc.1994-11-02
ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER (K941814)Sherwood Medical Co.1994-09-30
ARGYLE NEO-SERT (K942564)Sherwood Medical Co.1994-08-25
UMBILI-CATH-S (K940953)Gesco Intl., Inc.1994-08-02
UMBILI-CATH (K940870)Gesco Intl., Inc.1994-08-02
UMBILI-CATH-S-DL (K940952)Gesco Intl., Inc.1994-07-29
UMBILI-CATH-P (K940871)Gesco Intl., Inc.1994-04-29
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH (K921352)Vygon Corp.1992-10-26
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER (K921374)Vygon Corp.1992-10-26
GESCO UMBILI-CATH (K911607)Gesco Intl., Inc.1991-06-11
GESCO DUAL LUMEN UMBILICATH II-DL (K896041)Gesco Intl., Inc.1990-04-17
BARD UMBILICAL VESSEL CATHETER (K890685)C.R. Bard, Inc.1989-02-28
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER (K850884)Sherwood Medical Co.1985-10-17
XRO UMBILICAL CATHETER-CODE 270 (K851005)Vygon Corp.1985-05-21
UMBILICAL VESSEL CATHETER (K840339)Catheter Technology Corp.1984-07-25
INTRAVASCULAR CATHETER (K831988)C.R. Bard, Inc.1983-11-08
UMBILI-CATH CATHETER (K802414)Int'L Corp.1980-10-23
CATHETER, UMBILICAR ARTERY (K771022)Axiom Medical, Inc.1977-11-29
CATHETER, UMBILICAL, VICRA (K771891)Travenol Laboratories, S.A.1977-11-02
CATHETER, UMBILICAL ARTERY (K760966)Sherwood Medical Industries1977-01-26

Track FOS automatically

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