Cleared Traditional

K926570 - HOLLISTER BEDSIDE DRAINAGE COLLECTION S...

K926570 is an FDA 510(k) clearance for HOLLISTER BEDSIDE DRAINAGE COLLECTION S..., manufactured by Hollister, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K926570 · Hollister, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
May 1993
Decision
141d
Days
Class 2
Risk

K926570 is an FDA 510(k) clearance for the HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Hollister, Inc. (Libertyville, US). The FDA issued a Cleared decision on May 21, 1993 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hollister, Inc. devices

FDA 510(k) Submission Details - K926570

510(k) Number K926570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date May 21, 1993
Days to Decision 141 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 130d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNX Device Classification - Class 2, Special Controls

Product Code KNX Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5250
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 - KNX Collector, Urine, (and Accessories) For Indwelling Catheter

All 80
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K926570.
NEEDLELESS URINE SAMPLING PORT
K944236 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1994
BARD URINE COLLECTION PRODUCTS MODIFICATION
K940206 · C.R. Bard, Inc. · Sep 1994
KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER
K931459 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1993
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
K913223 · Medical Device Inspection Co., Inc. · Sep 1991
URINE COLLECTOR LEG BAG
K896688 · Medline Industries, Inc. · May 1990
KENDALL KENGUARD URINARY LEG BAGS
K892437 · The Kendal Co. · Jun 1989