Cleared Traditional

K880034 - CLOSED URINARY DRAINAGE BAG W/ANTI-REFL...

K880034 is an FDA 510(k) clearance for CLOSED URINARY DRAINAGE BAG W/ANTI-REFL..., manufactured by Lin-Mark, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K880034 · Lin-Mark, Inc. · Gastroenterology & Urology device
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Mar 1988
Decision
57d
Days
Class 2
Risk

K880034 is an FDA 510(k) clearance for the CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Lin-Mark, Inc. (Tampa, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 57 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 Lin-Mark, Inc. devices

FDA 510(k) Submission Details - K880034

510(k) Number K880034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date March 02, 1988
Days to Decision 57 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
73d faster than avg
Panel avg: 130d · This submission: 57d
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 81
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K880034.
KENDALL KENGUARD URINARY LEG BAGS
K892437 · The Kendal Co. · Jun 1989
KENDALL CURITY URINARY DRAINAGE BAGS
K892433 · The Kendal Co. · May 1989
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678 · Hollister, Inc. · Aug 1988
URETHAL CATHETER
K874309 · Medovations, Inc. · Dec 1987
CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)
K871610 · Coloplast A/S · Jun 1987
CONVEEN(R) LEG-BAG (600 ML)
K871643 · Coloplast A/S · Jun 1987