Cleared Traditional

K880299 - REPLICARE

K880299 · United Medical · General & Plastic Surgery device
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Feb 1988
Decision
32d
Days
-
Risk

K880299 is an FDA 510(k) clearance for the REPLICARE. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by United Medical (Largo, US). The FDA issued a Cleared decision on February 26, 1988 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 United Medical devices

Submission Details

510(k) Number K880299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date February 26, 1988
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 224
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K880299.
DUODERM(R) HYDROACTIVE(R) PASTE
K881302 · Convatec, A Division of E.R. Squibb & Sons · Apr 1988
TEGASORB ULCER DRESSING #90-XXX
K872298 · 3M Company · Apr 1988
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · Smith & Nephew, Inc. · Mar 1988
DERMATOLOGICAL PATCH
K872926 · Convatec, A Division of E.R. Squibb & Sons · Feb 1988
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987