Cleared Traditional

K851840 - STOMAHESIVE SKIN BARRIER STERILE

K851840 is an FDA 510(k) clearance for STOMAHESIVE SKIN BARRIER STERILE, manufactured by Convatec, A Division of E.R. Squibb & Sons. The device is a Class 1 Gastroenterology & Urology device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K851840

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
72d faster than avg
Panel avg: 131d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

EXB Device Classification - Class 1, General Controls

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 70
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K851840.
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019 · Convatec, A Division of E.R. Squibb & Sons · Apr 1986
MEDI-WIPES UNITED ANTISEPTIC SKIN PREP
K854726 · Pfizer, Inc. · Feb 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
UNITED SKIN BARRIERS
K844938 · Pfizer, Inc. · Jan 1985