510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954216Substantially Equivalent

Olympic Warm-Bassinet

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

K954216 is the FDA 510(k) clearance record for OLYMPIC WARM-BASSINET, a class I device, cleared for Olympic Medical Corp. on under FDA product code FOH (Mattress, Water, Temperature Regulated). FDA records list 37 510(k) clearances for Olympic Medical Corp., from to . As of , FDA records show no recalls naming K954216.

Clearance record

Decision date
Received
(93 days to decision)
Product code
FOH Mattress, Water, Temperature Regulated
Regulation
21 CFR 880.5560
Device class
Class I
Review panel
General Hospital
Applicant
Olympic Medical Corp. 5900 First Ave. S., Seattle WA
510(k) summary
Summary
Third party review
No

Clearances, product code FOH

Trailing 12 months

FDA records hold no clearances under product code FOH in the trailing twelve months.

FDA records show no clearances under product code FOH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FOH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260