Cleared Traditional

K913679 - UNIVERSAL SWIVEL PATCH

K913679 is an FDA 510(k) clearance for UNIVERSAL SWIVEL PATCH, manufactured by Bryman Medical. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K913679 · Bryman Medical · Gastroenterology & Urology device
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Sep 1991
Decision
17d
Days
Class 2
Risk

K913679 is an FDA 510(k) clearance for the UNIVERSAL SWIVEL PATCH. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Bryman Medical (Huntington Beach, US). The FDA issued a Cleared decision on September 5, 1991 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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 Bryman Medical devices

FDA 510(k) Submission Details - K913679

510(k) Number K913679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date September 05, 1991
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 130d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K913679.
GUIDEWIRE
K921200 · Lake Region Mfg., Inc. · Sep 1992
KENDALL CURITY KIDS PEDIATRIC DRAINAGE ADAPTER
K921055 · Kendall Healthcare Products Co. Div.Of Tyco Health · May 1992
MENTOR INFUSION LINE
K912919 · Mentor Corp. · Dec 1991
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
TECNOL CATHETER LEG STRAP
K882641 · Tecnol New Jersey Wound Care, Inc. · Jul 1988