Cleared Traditional

K924755 - CONVATEC LITTLE ONES PEDIATRIC URINE CO...

K924755 is the FDA 510(k) clearance for CONVATEC LITTLE ONES PEDIATRIC URINE CO... by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 Chemistry device (product code EXI) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K924755 · Convatec, A Division of E.R. Squibb & Sons · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
272d
Days
Class 1
Risk

K924755 is an FDA 510(k) clearance for the CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION. Classified as Device, Paste-on For Incontinence, Sterile (product code EXI), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 272 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 876.5250 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K924755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1992
Decision Date June 22, 1993
Days to Decision 272 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 88d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXI Device, Paste-on For Incontinence, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EXI Device, Paste-on For Incontinence, Sterile

Devices cleared under the same product code (EXI) and FDA review panel - the closest regulatory comparables to K924755.
HOLLISTER RETRACTED PENIS POUCH
K970443 · Hollister, Inc. · Feb 1997
HOLLISTER PREMIUM URINE COLLECTOR
K931277 · Hollister, Inc. · Jun 1993
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
K915246 · Coloplast A/S · Feb 1992
URIHESIVE STRIP
K915616 · Convatec, A Division of E.R. Squibb & Sons · Jan 1992