Atlas FDA

ATS 5000 Automatic Tourniquet Instrument

FDA 510(k) clearance K202919 · decided 2021-05-20

Clearance details

K-number
K202919
Device name
ATS 5000 Automatic Tourniquet Instrument
Applicant
Mcewen and Associates Consulting , Ltd.
Decision
Substantially Equivalent
Date received
2020-09-29
Decision date
2021-05-20
Days to decision
233 days
Clearance type
Traditional
Product code
KCY
Device class
1
Regulation number
878.5910
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Vancouver, CA
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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

Recalls involving this device

RecordFirmDate
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S. 5000TS Tourniquet Systems Model recall (Z-1201-2026)Zimmer Surgical Inc2026-01-28