Cleared Traditional

K812501 - OPRAFLEX

K812501 · Selomas, Inc. · General & Plastic Surgery device
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Oct 1981
Decision
32d
Days
-
Risk

K812501 is an FDA 510(k) clearance for the OPRAFLEX. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Selomas, Inc. (Walker, US). The FDA issued a Cleared decision on October 2, 1981 after a review of 32 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 Selomas, Inc. devices

FDA 510(k) Submission Details - K812501

510(k) Number K812501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date October 02, 1981
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 600
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K812501.
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HYPERALIMENTATION DRESSING CHANGE TRAY
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ZINC PASTE BANDAGE
K802791 · Secol Co. · Dec 1980