Cleared Traditional

K895957 - L.T.C. 1000 URINARY DRAINAGE BAG

K895957 is an FDA 510(k) clearance for L.T.C. 1000 URINARY DRAINAGE BAG, manufactured by Intl. Medical Marketing, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K895957 · Intl. Medical Marketing, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
13d
Days
Class 2
Risk

K895957 is an FDA 510(k) clearance for the L.T.C. 1000 URINARY DRAINAGE BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Intl. Medical Marketing, Inc. (Ridge, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 13 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 Intl. Medical Marketing, Inc. devices

FDA 510(k) Submission Details - K895957

510(k) Number K895957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date October 24, 1989
Days to Decision 13 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
117d faster than avg
Panel avg: 130d · This submission: 13d
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 K895957.
HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
K926570 · Hollister, Inc. · May 1993
STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES
K913223 · Medical Device Inspection Co., Inc. · Sep 1991
URINE COLLECTOR LEG BAG
K896688 · Medline Industries, Inc. · May 1990
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