Cleared Traditional

K945204 - URINE COLLECTOR & ACCESSORIES

K945204 is an FDA 510(k) clearance for URINE COLLECTOR & ACCESSORIES, manufactured by Nelmed Corp.. The device is a Class 1 Gastroenterology & Urology device with product code FAQ cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K945204 · Nelmed Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
8d
Days
Class 1
Risk

K945204 is an FDA 510(k) clearance for the URINE COLLECTOR & ACCESSORIES. Classified as Bag, Urine Collection, Leg, For External Use, Sterile (product code FAQ), Class I - General Controls.

Submitted by Nelmed Corp. (North Attleboro, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 8 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.

View all Nelmed Corp. devices

FDA 510(k) Submission Details - K945204

510(k) Number K945204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1994
Decision Date November 02, 1994
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
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 10
Devices cleared under the same product code (FAQ) and FDA review panel - the closest regulatory comparables to K945204.
PROSYS BEDSIDE DRAINAGE BAG
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PROSYS LEG BAG
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K926035 · C.R. Bard, Inc. · Dec 1992
CONVEEN(R) LEG BAG(500 ML)
K924406 · Coloplast A/S · Oct 1992
EXTERNAL LEG BAG
K901219 · Orion Life Systems, Inc. · Jun 1990