Cleared Traditional

DRAINING-WOUND MGMT. SYSTEM (K810812) - FDA 510(k) Clearance

Class I Chemistry device.

K810812 · Johnson & Johnson Professionals, Inc. · Chemistry device
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Apr 1981
Decision
24d
Days
Class 1
Risk

K810812 is an FDA 510(k) clearance for the DRAINING-WOUND MGMT. SYSTEM. Classified as Collector, Ostomy (product code EXB), Class I - General Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 876.5900 - the FDA in vitro diagnostics and chemistry 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K810812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1981
Decision Date April 17, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 21
Devices cleared under the same product code (EXB) and FDA review panel - the closest regulatory comparables to K810812.
BARD PROTECTIVE BARRIER FILM
K821271 · C.R. Bard, Inc. · Jul 1982
WOUND DRAINAGE MANAGEMENT SYSTEMS
K813080 · Howmedica Corp. · Nov 1981
FORMULATION CHANGE IN UNITED SKIN BARR
K810726 · Howmedica Corp. · Jun 1981
ADHESIVE PERISTOMAL COVERING W/WO CONN.
K803082 · Johnson & Johnson Professionals, Inc. · Dec 1980
CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON
K802677 · Johnson & Johnson Professionals, Inc. · Nov 1980
SUPER BANISH DEODORANT
K801471 · Howmedica Corp. · Jul 1980