Atlas FDA

KGZ

29 FDA 510(k) clearances · Product code

41 daysmedian time to decision
89 days90th percentile
29clearances measured

FDA profile

Official device name
Accessories, Catheter
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 36 · 2022: 88 · 2023: 55 · 2024: 44 · 2025: 31 · 2026: 34
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
AART SILICONE TUBING (K022306)Aesthetic and Reconstructive Technologies, Inc.2002-10-10
BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (K974295)Byron Medical1998-02-10
WOUND DRAINAGE HOLDER (K973183)R & D Medical Products, Inc.1998-01-23
DURALASTIC SILICONE TUBING (K955433)Allied Biomedical Corp.1996-01-26
NAVARRE PERCUTANEOUS ACCESS SET (K942315)Navarre Biomedical , Ltd.1994-07-08
PALESTRANT IRRIGATION AND DRAINAGE SET (K896087)North American Instrument Corp.1989-11-03
OPTICAL CATHETER(TM) INTRODUCER SETS (K895041)Medical Dynamics, Inc.1989-10-16
DESERET PRN ADAPTER (K893406)Deseret Medical, Inc.1989-06-22
CONCEPT SWITCHING STICK (K873009)Concept, Inc.1987-08-17
HCI GENERAL PURPOSE CATHETER STYLET (K870014)Health Care Innovations, Inc.1987-02-06
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (K864115)Cathaid, Inc.1986-11-07
ANGIO MED DISPOSABLE PRESSURE CONNECTORS (K855078)Angiomed U.S., Inc.1986-02-19
NU-THOR THORACOSTOMY KIT (K842666)Intl. Medical Devices , Ltd.1984-09-20
DESERET UNIVERSAL LUER LOCK (K821525)Warner-Lambert Co.1982-06-23
DESERET OFFSET PRN ADAPTER (K821245)Warner-Lambert Co.1982-05-13
PERI-PATCH GLUE MOLD (K810530)Quinton, Inc.1981-03-24
PERI-PATCH PERITONEAL CATHETER EXTENSION (K810531)Quinton, Inc.1981-03-24
ARROW CATHETER CLAMP (K802367)Arrow Intl., Inc.1980-10-23
ARGLE LATEX PENROSE TUBING (K802286)Sherwood Medical Co.1980-10-23
CONPHAR ADAPT-CONNECTS STERILE, NONSTE. (K791806)Conphar, Inc.1979-09-21
CONPHAR CATHETER PLUG (K791803)Conphar, Inc.1979-09-21
SENSOMAT SIDEARM ADAPTER (K790597)Biochem International, Inc.1979-07-10
ADAPTER, CATHETER SHEATH (K781846)Arrow Intl., Inc.1978-12-12
PAD, B-D I.V. CATH. (K781854)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-12-04
CATHETERIZATION TRAY & KIT (K780259)Argon Medical Corp.1978-04-18
3-WAY STOPCOCK WITH LUER-LOCK FITTING (K770154)American Viggo1977-02-28
STOPPERS (K760384)B. Braun Instruments1976-11-02
EXTENSION SETS (K760385)B. Braun Instruments1976-11-02
STOPCOCKS (K760383)B. Braun Instruments1976-11-02

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