Cleared Traditional

SUR-FIT NIGHT DRAINAGE CONTAINER SET (K842395) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842395 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Aug 1984
Decision
50d
Days
Class 2
Risk

K842395 is an FDA 510(k) clearance for the SUR-FIT NIGHT DRAINAGE CONTAINER SET. Classified as Collector, Urine, (and Accessories) For Indwelling Catheter (product code KNX), Class II - Special Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Mchenry, US). The FDA issued a Cleared decision on August 8, 1984 after a review of 50 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K842395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date August 08, 1984
Days to Decision 50 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
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (KNX) and FDA review panel - the closest regulatory comparables to K842395.
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · Travenol Laboratories, S.A. · Apr 1986
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · C.R. Bard, Inc. · Jul 1985
TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE
K844280 · Travenol Laboratories, S.A. · Dec 1984
CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE
K832290 · Travenol Laboratories, S.A. · Jul 1984
CLOSED SYS. DRAINAGE BAGS & TRAYS
K832822 · Medline Industries, Inc. · Oct 1983
LEG DRAINAGE BAG STRAP BK6011
K831553 · Fred Sammons, Inc. · Jun 1983