Cleared Traditional

K896129 - URINARY LEG BAG

K896129 is an FDA 510(k) clearance for URINARY LEG BAG, manufactured by Cypress Medical Products, Ltd.. The device is a Class 1 Gastroenterology & Urology device with product code FAQ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K896129 · Cypress Medical Products, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
175d
Days
Class 1
Risk

K896129 is an FDA 510(k) clearance for the URINARY LEG BAG. Classified as Bag, Urine Collection, Leg, For External Use, Sterile (product code FAQ), Class I - General Controls.

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 175 days - an extended review 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: 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 Cypress Medical Products, Ltd. devices

FDA 510(k) Submission Details - K896129

510(k) Number K896129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1989
Decision Date April 16, 1990
Days to Decision 175 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 130d · This submission: 175d
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 K896129.
BARD LEG BAG HOLDER
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
QUADRIPLEGIC URINARY DRAINAGE VALVE
K772402 · Fred Sammons, Inc. · Jan 1978
URINARY LEG BAG
K780032 · C.R. Bard, Inc. · Jan 1978