Cleared Traditional

K896727 - 4 SURE URINARY DRAIN BAG

K896727 is an FDA 510(k) clearance for 4 SURE URINARY DRAIN BAG, manufactured by The Boston & Pacific Co., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K896727 · The Boston & Pacific Co., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
83d
Days
Class 2
Risk

K896727 is an FDA 510(k) clearance for the 4 SURE URINARY DRAIN BAG. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by The Boston & Pacific Co., Inc. (Hingham, US). The FDA issued a Cleared decision on February 20, 1990 after a review of 83 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 The Boston & Pacific Co., Inc. devices

FDA 510(k) Submission Details - K896727

510(k) Number K896727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1989
Decision Date February 20, 1990
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
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 K896727.
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