Cleared Traditional

K844046 - UNITED SKIN BARRIERS

K844046 is the FDA 510(k) clearance for UNITED SKIN BARRIERS by Howmedica Corp.. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K844046 · Howmedica Corp. · Gastroenterology & Urology device
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Nov 1984
Decision
43d
Days
Class 1
Risk

K844046 is an FDA 510(k) clearance for the UNITED SKIN BARRIERS. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Howmedica Corp. (Ny, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5900 - 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 Howmedica Corp. devices

Submission Details

510(k) Number K844046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1984
Decision Date November 29, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXB Collector, Ostomy
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5900
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 - EXB Collector, Ostomy

All 55
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K844046.
JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT
K852297 · Johnson & Johnson Professionals, Inc. · Jun 1985
BARD PERISTOMAL PASTE
K851398 · C.R. Bard, Inc. · May 1985
COLOPLAST URO 2002 UROSTOMY SYSTEM
K844685 · Coloplast A/S · Jan 1985
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
K844406 · Johnson & Johnson Professionals, Inc. · Nov 1984
SUR-FIT IRRIGATION ADAPTER FACEPLATE
K842398 · Convatec, A Division of E.R. Squibb & Sons · Oct 1984
COMFEEL PROTECTIVE FILM
K833567 · Coloplast A/S · May 1984