Cleared Traditional

K955439 - THE REEL THING (MODIFICATION)

K955439 is an FDA 510(k) clearance for THE REEL THING (MODIFICATION), manufactured by Biomedical Devices, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

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

FDA 510(k) Submission Details - K955439

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.

GBX Device Classification - Class 1, General Controls

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 49
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K955439.
HYDROLOGY 5000
K955339 · Northgate Technologies, Inc. · Mar 1996
NEO-PNEUMOCATH
K955474 · Intra Special Catheters GmbH · Feb 1996
OPTI-DRAIN MULTI-USE DRAINAGE CATHETER
K955505 · Navarre Biomedical , Ltd. · Feb 1996
SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN
K926496 · Sil-Med Corp. · May 1995
ANGIOCATH SIDEHOLDER DRAINAGE CATHETER
K950437 · Becton Dickinson Vascular Access, Inc. · Mar 1995
INSYTE SIDEHOLDED DRAINAGE CATHETER
K950439 · Becton Dickinson Vascular Access, Inc. · Mar 1995