Cleared Traditional

K822990 - CONVERTORS PRIMARY WOUND DRESSING II

K822990 · American Hospital Supply Corp. · General & Plastic Surgery device
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Apr 1983
Decision
182d
Days
-
Risk

K822990 is an FDA 510(k) clearance for the CONVERTORS PRIMARY WOUND DRESSING II. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K822990

510(k) Number K822990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1982
Decision Date April 12, 1983
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 283
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K822990.
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
NON - ADHERENT BANDAGE
K833733 · American Medical Disposable, Inc. · Dec 1983
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708 · Convatec, A Division of E.R. Squibb & Sons · May 1983
PERFILM MEMBRANE DRESSING
K822467 · Chesebrough-Pond'S U.S.A. Co. · Dec 1982
CURITY TRANSPARENT FILM DRESSING
K822424 · The Kendal Co. · Dec 1982
DUODERM HYDROACTIVE GRANULES
K821655 · Convatec, A Division of E.R. Squibb & Sons · Oct 1982