510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K972193Substantially Equivalent

Olympix Mini-Pasteurmatic (58210)

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

K972193 is the FDA 510(k) clearance record for OLYMPIX MINI-PASTEURMATIC (58210), a class II device, cleared for Olympic Medical Corp. on under FDA product code LDS (Device, Pasteurization, Hot Water). FDA records list 37 510(k) clearances for Olympic Medical Corp., from to . As of , FDA records show no recalls naming K972193.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LDS Device, Pasteurization, Hot Water
Regulation
21 CFR 880.6991
Device class
Class II
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 LDS

Trailing 12 months

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

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