Cleared Traditional

K822990 - CONVERTORS PRIMARY WOUND DRESSING II

K822990 · American Hospital Supply Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 115d · This submission: 182d
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 K822990.
DECUBITUS CARE ABSORBENT DRESSING
K832407 · American Pharmaseal Div. Ahsc · Jan 1984
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
DUO DERM FLEX HYDROACTIVE DRESSINGS &
K830708 · Convatec, A Division of E.R. Squibb & Sons · May 1983
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