Cleared Traditional

K832407 - DECUBITUS CARE ABSORBENT DRESSING

K832407 · American Pharmaseal Div. Ahsc · General & Plastic Surgery device
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Jan 1984
Decision
182d
Days
-
Risk

K832407 is an FDA 510(k) clearance for the DECUBITUS CARE ABSORBENT DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by American Pharmaseal Div. Ahsc (Walker, US). The FDA issued a Cleared decision on January 19, 1984 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 Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K832407

510(k) Number K832407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1983
Decision Date January 19, 1984
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 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K832407.
HYDRON WOUND DRESSING FAST SEAT KIT
K832699 · National Patent Development Corp. · Apr 1984
STERILE ABSORBENT GAUZE BURN & SOUND
K840745 · Chesebrough-Pond'S U.S.A. Co. · Apr 1984
NON ADHERENT BANDAGE/SHEET
K833730 · American Medical Disposable, Inc. · Jan 1984
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