Cleared Traditional

K050411 - ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM

K050411 is an FDA 510(k) clearance for ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET..., manufactured by Zimmer, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCY cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K050411 · Zimmer, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
197d
Days
Class 1
Risk

K050411 is an FDA 510(k) clearance for the ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on September 2, 2005 after a review of 197 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K050411

510(k) Number K050411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2005
Decision Date September 02, 2005
Days to Decision 197 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 115d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

KCY Device Classification - Class 1, General Controls

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KCY Tourniquet, Pneumatic

All 17
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K050411.
T-Cuff
K162365 · Terumobct, Inc. · Feb 2017
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · Zimmer, Inc. · Aug 2013
EZ VEIN INFLATABLE TOURNIQUET
K112874 · Dominion Medical Devices, LLC · Oct 2011
EXPRESSAIRE TORUNIQUET SYSTEM
K955552 · Smith & Nephew Richards, Inc. · Jan 1996
BUONAFEDE PNEUMATIC SLEEVE
K954201 · Promedic, Inc. · Nov 1995
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
K953953 · Deroyal Industries, Inc. · Sep 1995