Cleared Traditional

THE REEL THING (MODIFICATION) (K955439) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K955439 · Biomedical Devices, Inc. · General & Plastic Surgery device
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Dec 1995
Decision
43d
Days
Class 1
Risk

K955439 is an FDA 510(k) clearance for the THE REEL THING (MODIFICATION). Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Biomedical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 43 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 Biomedical Devices, Inc. devices

Submission Details

510(k) Number K955439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date December 26, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
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 7
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K955439.
CLOSED FLUID COLLECTION SYSTEM
K961147 · B.Braun Medical, Inc. · May 1996
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
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496 · Travenol Laboratories, S.A. · Dec 1982