Cleared Traditional

K833625 - ACTIVE LIFE

K833625 is the FDA 510(k) clearance for ACTIVE LIFE by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 Gastroenterology & Urology device (product code EXB) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K833625 · Convatec, A Division of E.R. Squibb & Sons · Gastroenterology & Urology device
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Nov 1983
Decision
45d
Days
Class 1
Risk

K833625 is an FDA 510(k) clearance for the ACTIVE LIFE. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 45 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

Submission Details

510(k) Number K833625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date November 28, 1983
Days to Decision 45 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
85d faster than avg
Panel avg: 130d · This submission: 45d
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 65
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K833625.
STERILE DRAINAGE SYSTEM
K833571 · Coloplast A/S · Jan 1984
COMFEEL CLEANSER
K833566 · Coloplast A/S · Dec 1983
COMFEEL BARRIER CREAM
K833569 · Coloplast A/S · Dec 1983
SUR-FIT FLEXIBLE
K830945 · Convatec, A Division of E.R. Squibb & Sons · Apr 1983
BARD PROTECTIVE BARRIER FILM
K821271 · C.R. Bard, Inc. · Jul 1982
HOLLISTER CATHETER ACCESS. PORT
K821680 · Hollister, Inc. · Jun 1982