Cleared Traditional

K880788 - NON ADHERENT PAD

K880788 · Cederroth, Inc. USA · General & Plastic Surgery device
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Apr 1988
Decision
35d
Days
-
Risk

K880788 is an FDA 510(k) clearance for the NON ADHERENT PAD. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Cederroth, Inc. USA (Englewood, US). The FDA issued a Cleared decision on April 1, 1988 after a review of 35 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 Cederroth, Inc. USA devices

Submission Details

510(k) Number K880788 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 26, 1988
Decision Date April 01, 1988
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 199
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K880788.
HYDROCOLLOID DRESSING FOR PSORIASIS
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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