510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081094Substantially Equivalent

Olympic Pasteurmatic, Models 3000 and 3500

Olympic Medical Corp., Seattle WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081094 is the FDA 510(k) clearance record for OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500, a class II device, cleared for Olympic Medical Corp. on under FDA product code MEC (Disinfector, Medical Devices). FDA records list 37 510(k) clearances for Olympic Medical Corp., from to . As of , FDA records show one recall naming K081094.

Clearance record

Decision date
Received
(64 days to decision)
Product code
MEC Disinfector, Medical Devices
Regulation
21 CFR 880.6992
Device class
Class II
Review panel
General Hospital
Applicant
Olympic Medical Corp. 5900 First Ave. S., Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEC

Trailing 12 months

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

FDA records show no clearances under product code MEC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MEC, 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