Cleared Traditional

K832699 - HYDRON WOUND DRESSING FAST SEAT KIT

K832699 · National Patent Development Corp. · General & Plastic Surgery device
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Apr 1984
Decision
261d
Days
-
Risk

K832699 is an FDA 510(k) clearance for the HYDRON WOUND DRESSING FAST SEAT KIT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by National Patent Development Corp. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1984 after a review of 261 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 National Patent Development Corp. devices

FDA 510(k) Submission Details - K832699

510(k) Number K832699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1983
Decision Date April 27, 1984
Days to Decision 261 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
146d slower than avg
Panel avg: 115d · This submission: 261d
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 K832699.
AQUAPHOR R GAUZE
K842967 · Beiersdorf, Inc. · Nov 1984
COMFEEL ULCUS SHEET
K840438 · Coloplast A/S · Nov 1984
DUODERM FLEXIBLE HYDROACTIVE DRESSINGS
K841287 · Convatec, A Division of E.R. Squibb & Sons · Aug 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
DECUBITUS CARE ABSORBENT DRESSING
K832407 · American Pharmaseal Div. Ahsc · Jan 1984