Cleared Traditional

K781373 - OSTOMY APPLIANCE W/DEODORIZING FILTER

K781373 is an FDA 510(k) clearance for OSTOMY APPLIANCE W/DEODORIZING FILTER, manufactured by Hollister, Inc.. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K781373 · Hollister, Inc. · Gastroenterology & Urology device
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Sep 1978
Decision
44d
Days
Class 1
Risk

K781373 is an FDA 510(k) clearance for the OSTOMY APPLIANCE W/DEODORIZING FILTER. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Hollister, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 44 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 Hollister, Inc. devices

FDA 510(k) Submission Details - K781373

510(k) Number K781373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1978
Decision Date September 20, 1978
Days to Decision 44 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
86d faster than avg
Panel avg: 130d · This submission: 44d
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 68
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K781373.
HOLLISTER STOMA POUCH WITH MICRO ADHES
K791535 · Hollister, Inc. · Oct 1979
HOLLISTER UROSTOMY POUCH
K791534 · Hollister, Inc. · Oct 1979
COLOPLAST CARBON GAS FILTER
K791581 · C.R. Bard, Inc. · Oct 1979
OSTOMY APPLIANCE BELT
K781088 · E. R. Squibb & Sons, Inc. · Aug 1978
ACTIVE-LIFE
K780454 · E. R. Squibb & Sons, Inc. · Apr 1978
SNAP-FIT
K780511 · E. R. Squibb & Sons, Inc. · Apr 1978