Cleared Traditional

K781987 - URINARY DRAINAGE BAG

K781987 is the FDA 510(k) clearance for URINARY DRAINAGE BAG by Kelsar Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNY) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K781987 · Kelsar Corp. · Gastroenterology & Urology device
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Dec 1978
Decision
10d
Days
Class 2
Risk

K781987 is an FDA 510(k) clearance for the URINARY DRAINAGE BAG. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Kelsar Corp. (Mchenry, US). The FDA issued a Cleared decision on December 4, 1978 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 Kelsar Corp. devices

Submission Details

510(k) Number K781987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1978
Decision Date December 04, 1978
Days to Decision 10 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
120d faster than avg
Panel avg: 130d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KNY Accessories, Catheter, G-u

All 24
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K781987.
CATHETER PLUG/PROTECTOR
K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
TECNOL CATHETER LEG STRAP
K882641 · Tecnol New Jersey Wound Care, Inc. · Jul 1988
DEFLECTING GUIDE WIRE
K833242 · Van-Tec, Inc. · Oct 1983
SAFEED DISP. PLASTIC CATHETER
K771212 · Terumo America, Inc. · Sep 1977
SILASTIC BRAND GASTRIC LAVAGE TUBE
K760943 · Dow Corning Corp. Healthcare Industries Materials · Nov 1976