510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920423Substantially Equivalent

Olympic Smart Scale Care Center

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

K920423 is the FDA 510(k) clearance record for OLYMPIC SMART SCALE CARE CENTER, a class II device, cleared for Olympic Medical Corp. on under FDA product code FEW (Catheter, Malecot). FDA records list 37 510(k) clearances for Olympic Medical Corp., from to . As of , FDA records show no recalls naming K920423.

Clearance record

Decision date
Received
(132 days to decision)
Product code
FEW Catheter, Malecot
Regulation
21 CFR 876.5090
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympic Medical Corp. 5900 First Ave. S., Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code FEW

Trailing 12 months

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

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