Cleared Traditional

K813365 - MULTIPLE BANDAGE OR DRESSING

K813365 · Cederroth, Inc. USA · General & Plastic Surgery device
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Feb 1982
Decision
66d
Days
-
Risk

K813365 is an FDA 510(k) clearance for the MULTIPLE BANDAGE OR DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Cederroth, Inc. USA (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 66 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 K813365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1981
Decision Date February 04, 1982
Days to Decision 66 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
49d faster than avg
Panel avg: 115d · This submission: 66d
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 K813365.
DUODERM HYDROACTIVE GRANULES
K821655 · Convatec, A Division of E.R. Squibb & Sons · Oct 1982
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K821656 · Convatec, A Division of E.R. Squibb & Sons · Sep 1982
PVP GEL DRESSING
K820635 · Johnson & Johnson Professionals, Inc. · Aug 1982
TEGADERM TRANSPARENT DRESSING
K812678 · 3M Company · Jan 1982