510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801461Substantially Equivalent

Therma-Shield

Olympic Medical Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801461 is the FDA 510(k) clearance record for THERMA-SHIELD, a class II device, cleared for Olympic Medical Corp. on under FDA product code FMZ (Incubator, Neonatal). FDA records list 37 510(k) clearances for Olympic Medical Corp., from to . As of , FDA records show no recalls naming K801461.

Clearance record

Decision date
Received
(34 days to decision)
Product code
FMZ Incubator, Neonatal
Regulation
21 CFR 880.5400
Device class
Class II
Review panel
General Hospital
Applicant
Olympic Medical Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FMZ

Trailing 12 months
2 clearances under product code FMZ in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FMZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260