Cleared Traditional

K791581 - COLOPLAST CARBON GAS FILTER

K791581 is the FDA 510(k) clearance for COLOPLAST CARBON GAS FILTER by C.R. Bard, Inc.. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K791581 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Oct 1979
Decision
48d
Days
Class 1
Risk

K791581 is an FDA 510(k) clearance for the COLOPLAST CARBON GAS FILTER. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1979 after a review of 48 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K791581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1979
Decision Date October 02, 1979
Days to Decision 48 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
82d faster than avg
Panel avg: 130d · This submission: 48d
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 K791581.
HOLLISTER STOMA POUCH SKIN BARRIER
K791526 · Hollister, Inc. · Oct 1979
HOLLISTER STOMA POUCH WITH MICRO ADHES
K791535 · Hollister, Inc. · Oct 1979
HOLLISTER UROSTOMY POUCH
K791534 · Hollister, Inc. · Oct 1979
OSTOMY APPLIANCE W/DEODORIZING FILTER
K781373 · Hollister, Inc. · Sep 1978
COLORPLAST TRANSVERSE SYSTEM
K771775 · C.R. Bard, Inc. · Sep 1977
STOMA BAG W/SKIN BARRIER SEAL RING
K770439 · Hollister, Inc. · Apr 1977