Cleared Traditional

OSTOMY OR UROSTOMY ABDOMINAL BELT OS (K842119) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K842119 · Atlas Surgical Belt Co., Inc. · Gastroenterology & Urology device
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Sep 1984
Decision
110d
Days
Class 1
Risk

K842119 is an FDA 510(k) clearance for the OSTOMY OR UROSTOMY ABDOMINAL BELT OS. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Atlas Surgical Belt Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 10, 1984 after a review of 110 days - within the typical 510(k) review window.

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

View all Atlas Surgical Belt Co., Inc. devices

Submission Details

510(k) Number K842119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1984
Decision Date September 10, 1984
Days to Decision 110 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
20d faster than avg
Panel avg: 130d · This submission: 110d
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 22
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K842119.
BARD PERISTOMAL PASTE
K851398 · C.R. Bard, Inc. · May 1985
UNITED SKIN BARRIERS
K844046 · Howmedica Corp. · Nov 1984
JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN
K844406 · Johnson & Johnson Professionals, Inc. · Nov 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · Howmedica Corp. · Apr 1984
BARD KARAYA GUM WASHERS
K834575 · C.R. Bard, Inc. · Feb 1984
BARD PROTECTIVE BARRIER FILM
K821271 · C.R. Bard, Inc. · Jul 1982