Cleared Traditional

K851840 - STOMAHESIVE SKIN BARRIER STERILE

K851840 is the FDA 510(k) clearance for STOMAHESIVE SKIN BARRIER STERILE by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K851840 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Jun 1985
Decision
59d
Days
Class 1
Risk

K851840 is an FDA 510(k) clearance for the STOMAHESIVE SKIN BARRIER STERILE. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on June 24, 1985 after a review of 59 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 Convatec, A Division of E.R. Squibb & Sons devices

Submission Details

510(k) Number K851840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date June 24, 1985
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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 65
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K851840.
COLOPLAST CONVEX RING
K861070 · Coloplast A/S · Jun 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019 · Convatec, A Division of E.R. Squibb & Sons · Apr 1986
DURAHESIVE WAFER WITH FLANGE
K855018 · Convatec, A Division of E.R. Squibb & Sons · Feb 1986
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