Cleared Traditional

K813535 - XEROFORM DRESSING

K813535 · W.G. Whitney Corp. · General & Plastic Surgery device
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Feb 1982
Decision
49d
Days
-
Risk

K813535 is an FDA 510(k) clearance for the XEROFORM DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by W.G. Whitney Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 49 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 W.G. Whitney Corp. devices

Submission Details

510(k) Number K813535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1981
Decision Date February 04, 1982
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 224
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K813535.
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
DRESSING CHANGE FOR G TUBE
K803115 · American Medical Disposable, Inc. · Jan 1981
HYPERALIMENTATION DRESSING CHANGE TRAY
K803114 · American Medical Disposable, Inc. · Dec 1980