Atlas FDA

GAZ

27 FDA 510(k) clearances · Product code

34 daysmedian time to decision
115 days90th percentile
27clearances measured

FDA profile

Official device name
Tubing, Noninvasive
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6740
Medical specialty
General Hospital
Adverse events (MAUDE)
2020: 25 · 2021: 18 · 2023: 24 · 2024: 65 · 2025: 42 · 2026: 45
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SUCTION/IRRIGATOR TUBING KIT (K952605)Surgical Laser Technologies, Inc.1995-09-15
TUBING, NONINVASIVE (K945978)Endoscopic Technologies, Inc.1995-01-11
SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (K930512)Core Dynamics, Inc.1993-07-23
NORTEC CONNECTING TUBE SET (K911865)North American Sterilization & Packaging Co.1991-11-01
MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (K910471)Baxter Healthcare Corp1991-03-08
MAXI-FLOW SUCTION SET W/Y CONNECTOR (K910171)Adler Instrument Co.1991-02-01
MAXI-FLOW SUCTION SET 12 FT. (K910170)Adler Instrument Co.1991-02-01
VIR-A-VAC EMPTY (K882315)Viratec Corp.1988-09-26
SURGICAL CONNECTING TUBES (K883473)Westmark, Sterile Packing Systems, Inc. (Sps)1988-08-25
5 - IN - 1 CONNECTOR (K864964)Medovations, Inc.1987-01-20
5 IN 1 CONNECTOR (K861757)Jackson Plastics, Inc.1986-06-06
PHARMA-PLAST SMOOTH BORE CONNECTORS (K843476)Zimmar Consulting , Ltd.1984-09-24
MMG CONNECTIVE TUBING (K840838)Medical Marketing Group1984-03-30
ASPIRATING TUBING (K832519)Wells Johnson Co.1983-10-20
STERILE 5 IN 1 CONNECTORS (K830835)Abco Dealers, Inc.1983-04-06
CONNECTOR 5 IN 1, T-CONNECTOR (K830901)Medical Specialists IN Packaging1983-04-06
STERILE SAFETY PINS (K830381)Devon Industries, Inc.1983-03-24
PLEUROFIX THORACENTESIS KIT (K820004)Burron Medical Products, Inc.1982-02-04
ARGYLE CONNECT TUBE-CON & NON (K802777)Sherwood Medical Co.1980-12-11
LATEX PENROSE TUBING CAT. #20400,414,416 (K802761)American Hospital Supply Corp.1980-11-19
FLUID ADMINISTRATION CAT.#14-923 (K790358)Norton Performance Plastics Corp.1979-03-21
FILTER SYSTEM, ALTNER DISPOSABLE (K790209)Orthopedic Equipment Co., Inc.1979-02-26
CONNECTING TUBE, CONDUCTIVE, SURG. (K781127)Seamless Hospital Products Co.1978-09-20
PVC LINES FOR MONITORING (K780985)Norton Performance Plastics Corp.1978-07-27
ASEPTIC TRANSFER SET (K780417)Heyer Schulte Corp.1978-04-18
THORACIC DRAINAGE SET, ARGYLE DUAL (K770920)Sherwood Medical Industries1977-06-24
TUBE, STERILE CONDUCTIVE CONNECTING (K760202)Ipco Corp.1976-07-19

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