Cleared Traditional

K905614 - JACKSON-PRATT

K905614 is the FDA 510(k) clearance for JACKSON-PRATT by Baxter Healthcare Corp. It is a Class 1 General & Plastic Surgery device (product code GBX) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

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.

View all Baxter Healthcare Corp devices

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 115d · 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.

Regulatory Peers - GBX Catheter, Irrigation

All 23
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K905614.
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
K925748 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
TURKEL ABDOMINAL PARACENTESIS SYSTEM
K924702 · Symbiosis Corp. · Jan 1993
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
K922739 · Hollister, Inc. · Aug 1992
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
K895516 · Arrow Intl., Inc. · Dec 1989
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · American Pharmaseal Div. Ahsc · Mar 1987
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · Vygon Corp. · May 1985