Cleared Traditional

K926035 - BARD LEG BAG HOLDER

K926035 is an FDA 510(k) clearance for BARD LEG BAG HOLDER, manufactured by C.R. Bard, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FAQ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K926035 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
16d
Days
Class 1
Risk

K926035 is an FDA 510(k) clearance for the BARD LEG BAG HOLDER. Classified as Bag, Urine Collection, Leg, For External Use, Sterile (product code FAQ), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on December 17, 1992 after a review of 16 days - a notably fast clearance cycle.

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: 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 - K926035

510(k) Number K926035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date December 17, 1992
Days to Decision 16 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 131d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

FAQ Device Classification - Class 1, General Controls

Product Code FAQ Bag, Urine Collection, Leg, For External Use, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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 - FAQ Bag, Urine Collection, Leg, For External Use, Sterile

All 17
Devices cleared under the same product code (FAQ) and FDA review panel - the closest regulatory comparables to K926035.
URINE COLLECTOR & ACCESSORIES
K945204 · Nelmed Corp. · Nov 1994
ALPINE REUSABLE LEG BAGS
K934052 · Sierra Laboratories, Inc. · Jan 1994
URINARY DRAINAGE BAG CADDY
K931727 · Neotech Products, Inc. · Jul 1993
CONVEEN(R) LEG BAG(500 ML)
K924406 · Coloplast A/S · Oct 1992
ILC LEG BAG HOLDER
K903611 · Inman Liebelt Corp. · Oct 1990
EXTERNAL LEG BAG
K901219 · Orion Life Systems, Inc. · Jun 1990
K926035 · BARD LEG BAG HOLDER
Download PDF FDA Summary C.R. Bard, Inc.