Cleared Traditional

K870430 - PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.

K870430 · Steridyne Laboratories, Inc. · General & Plastic Surgery device
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Apr 1987
Decision
69d
Days
-
Risk

K870430 is an FDA 510(k) clearance for the PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG.. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Steridyne Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on April 13, 1987 after a review of 69 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 - K870430

510(k) Number K870430 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 03, 1987
Decision Date April 13, 1987
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
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 607
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