Cleared Traditional

K851679 - OSTOMY BAGS COLOSTOMY

K851679 is an FDA 510(k) clearance for OSTOMY BAGS COLOSTOMY, manufactured by Dbt Medical , Ltd.. The device is a Class 1 Gastroenterology & Urology device with product code EXB cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K851679 · Dbt Medical , Ltd. · Gastroenterology & Urology device
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Jun 1985
Decision
65d
Days
Class 1
Risk

K851679 is an FDA 510(k) clearance for the OSTOMY BAGS COLOSTOMY. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Dbt Medical , Ltd. (Witney,0x8 7az, GB). The FDA issued a Cleared decision on June 27, 1985 after a review of 65 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 Dbt Medical , Ltd. devices

FDA 510(k) Submission Details - K851679

510(k) Number K851679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1985
Decision Date June 27, 1985
Days to Decision 65 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
65d faster than avg
Panel avg: 130d · This submission: 65d
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 69
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K851679.
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
STOMAHESIVE SKIN BARRIER STERILE
K851840 · Convatec, A Division of E.R. Squibb & Sons · Jun 1985
JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT
K852297 · Johnson & Johnson Professionals, Inc. · Jun 1985
BARD PERISTOMAL PASTE
K851398 · C.R. Bard, Inc. · May 1985