Atlas FDA

KCY

34 FDA 510(k) clearances · Product code

68 daysmedian time to decision
233 days90th percentile
34clearances measured

FDA profile

Official device name
Tourniquet, Pneumatic
Device class
Class I (low risk)
Regulation
21 CFR 878.5910
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 130 · 2022: 90 · 2023: 347 · 2024: 107 · 2025: 121 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ATS 5000 Automatic Tourniquet Instrument (K202919)Mcewen and Associates Consulting , Ltd.2021-05-20
T-Cuff (K162365)Terumobct, Inc.2017-02-16
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM (K123553)Zimmer, Inc.2013-08-09
EZ VEIN INFLATABLE TOURNIQUET (K112874)Dominion Medical Devices, LLC2011-10-17
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002 (K071140)Top Spins, Inc.2007-06-07
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (K050411)Zimmer, Inc.2005-09-02
TOURNIQUET CUFF; PNEUMATIC TOURNIQUET (K012632)Medical Instruments Technology, Inc.2001-10-26
EXPRESSAIRE TORUNIQUET SYSTEM (K955552)Smith & Nephew Richards, Inc.1996-01-05
BUONAFEDE PNEUMATIC SLEEVE (K954201)Promedic, Inc.1995-11-09
TOURNI-COMP (K954103)Scandinavian Medical JW AB1995-11-01
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF (K953953)Deroyal Industries, Inc.1995-09-29
CLEAN-CUFF (K952038)Instrumed, Inc.1995-07-11
ACCUTEST (K940615)Instrumed, Inc.1995-05-19
DJ MEDICAL PNEUMATIC TOURNIQUET (K945167)Dj Medical, Inc.1995-02-13
TECNADYNE T-CUFF (K942303)Technadyne Scientific, Inc.1994-07-20
ARTHREX TOURNIQUET FOR LEG HOLDER (K933994)Arthrex, Inc.1994-03-23
STILLE AUTOMATIC TOURNIQUET (K925033)Ferguson Medical1993-02-01
ACCUFLATE (K924273)Instrumed, Inc.1993-01-12
PRESTITCH (K910449)Crantec Co.1992-05-29
ACCUFLATE (K910512)Instrumed, Inc.1991-02-19
TCPM II TOURNIQUET CUFF PRESSURE MONITOR (K900104)Electromedics, Inc.1990-03-15
DISPOSABLE COLOR-CUFFS (K890014)Instrumed, Inc.1989-01-24
3 IN 1 AUTOMATIC TOURNIQUET (K880020)Systematics Mfg. & Tool Co., Inc.1988-03-17
TOURNIQUET PRESSURE REGULATOR (K871982)Avec Scientific Design Corp.1987-06-09
A.T.S. 1500 TOURNIQUET (K870784)Aspen Laboratories, Inc.1987-03-18
SINGLE AND DUAL TOURNIQUET CUFF (K860463)Aspen Laboratories, Inc.1986-02-25
DIGIKIT NONPNEUMATIC TOURNIQUET (K860095)Orthofab, Inc.1986-01-24
ATS 500 TOURNIQUET (K853802)Aspen Laboratories, Inc.1985-10-07
RHYS-DAVIES EXSANGUINATOR (K842963)Woodville Polymer Engineering, Ltd.1984-08-17
BANANA CUFF (K841558)Aspen Laboratories, Inc.1984-07-16
PRESSURE SENTRY TOURNIQUET (K840206)Richards Medical Co., Inc.1984-04-25
TOURNIQUET (K813231)Aspen Laboratories, Inc.1981-12-14
TEST PRESSURE GAUGE #6675-32 (K791759)Depuy, Inc.1979-10-04
DEVIN-NESTOR PNEUMATIC TOURNIQUET (K780988)Nestor Engineering Associates, Inc.1978-10-03

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