Cleared Traditional

K911955 - OLYMPIC WARMETTE

K911955 · Olympic Medical Corp. · General & Plastic Surgery device
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Jul 1991
Decision
79d
Days
-
Risk

K911955 is an FDA 510(k) clearance for the OLYMPIC WARMETTE.

Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on July 19, 1991 after a review of 79 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 Olympic Medical Corp. devices

FDA 510(k) Submission Details - K911955

510(k) Number K911955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1991
Decision Date July 19, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

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