Cleared Traditional

CLOSED FLUID COLLECTION SYSTEM (K961147) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K961147 · B.Braun Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
71d
Days
Class 1
Risk

K961147 is an FDA 510(k) clearance for the CLOSED FLUID COLLECTION SYSTEM. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on May 31, 1996 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K961147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1996
Decision Date May 31, 1996
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
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 76
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K961147.
JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
K960955 · Baxter Healthcare Corp · May 1996
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
K925176 · Boston Scientific Corp · Apr 1993
JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS
K905614 · Baxter Healthcare Corp · Mar 1991
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984