Cleared Traditional

K905128 - FLEXI-TRAK(TM) ANCHORING DEVICE

K905128 is an FDA 510(k) clearance for FLEXI-TRAK(TM) ANCHORING DEVICE, manufactured by Convatec, A Division of E.R. Squibb & Sons. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K905128 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Nov 1990
Decision
15d
Days
Class 2
Risk

K905128 is an FDA 510(k) clearance for the FLEXI-TRAK(TM) ANCHORING DEVICE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 15 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.

FDA 510(k) Submission Details - K905128

510(k) Number K905128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1990
Decision Date November 29, 1990
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 131d · This submission: 15d
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 64
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K905128.
CATH CONTROL
K914211 · Highpoint Medical Corp. · Nov 1991
UNIVERSAL SWIVEL PATCH
K913679 · Bryman Medical · Sep 1991
URETERAL CATHETER HOLDER
K912146 · Inman Liebelt Corp. · Jul 1991
MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
K900031 · Porges Corp. · Mar 1990
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
K890072 · Medireach, Inc. · Jun 1989
K905128 · FLEXI-TRAK(TM) ANCHORING DEVICE
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