Cleared Traditional

K801461 - THERMA-SHIELD

K801461 is an FDA 510(k) clearance for THERMA-SHIELD, manufactured by Olympic Medical Corp.. The device is a Class 2 General Hospital device with product code FMZ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K801461 · Olympic Medical Corp. · General Hospital
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Jul 1980
Decision
34d
Days
Class 2
Risk

K801461 is an FDA 510(k) clearance for the THERMA-SHIELD. Classified as Incubator, Neonatal (product code FMZ), Class II - Special Controls.

Submitted by Olympic Medical Corp. (Walker, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5400 - the FDA general hospital device framework. 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 - K801461

510(k) Number K801461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date July 28, 1980
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMZ Device Classification - Class 2, Special Controls

Product Code FMZ Incubator, Neonatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.