Cleared Traditional

K911606 - BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K911606 · Baxter Healthcare Corp · General & Plastic Surgery device
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Jul 1991
Decision
90d
Days
Class 1
Risk

K911606 is an FDA 510(k) clearance for the BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on July 9, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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.

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Submission Details

510(k) Number K911606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 10, 1991
Decision Date July 09, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 114d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.