Cleared Traditional

K870431 - GAUZE, ABSORBENT, IODOFORM IMPREGNATED

K870431 · Steridyne Laboratories, Inc. · General & Plastic Surgery device
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Feb 1987
Decision
23d
Days
-
Risk

K870431 is an FDA 510(k) clearance for the GAUZE, ABSORBENT, IODOFORM IMPREGNATED. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Steridyne Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on February 26, 1987 after a review of 23 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 Steridyne Laboratories, Inc. devices

FDA 510(k) Submission Details - K870431

510(k) Number K870431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1987
Decision Date February 26, 1987
Days to Decision 23 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
92d faster than avg
Panel avg: 115d · This submission: 23d
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 601
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K870431.
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