510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830273Substantially Equivalent

Countway Sys. Soiled Sponges-Blood Los

Ritmed, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830273 is the FDA 510(k) clearance record for COUNTWAY SYS. SOILED SPONGES-BLOOD LOS, a class I device, cleared for Ritmed, Inc. on under FDA product code FQA (Scale, Surgical Sponge). FDA records list 22 510(k) clearances for Ritmed, Inc., from to . As of , FDA records show no recalls naming K830273.

Clearance record

Decision date
Received
(34 days to decision)
Product code
FQA Scale, Surgical Sponge
Regulation
21 CFR 880.2740
Device class
Class I
Review panel
General Hospital
Applicant
Ritmed, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FQA

Trailing 12 months

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

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