Cleared Traditional

K905614 - JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K905614 · Baxter Healthcare Corp · General & Plastic Surgery device
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Mar 1991
Decision
96d
Days
Class 1
Risk

K905614 is an FDA 510(k) clearance for the JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Niles, US). The FDA issued a Cleared decision on March 20, 1991 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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 K905614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date March 20, 1991
Days to Decision 96 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
18d faster than avg
Panel avg: 114d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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.