Cleared Traditional

ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM (K050411) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K050411 · Zimmer, Inc. · General & Plastic Surgery device
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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

Submission Details

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.

Device Classification

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.