510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810290Substantially Equivalent

Ohio Cal-Chek

Ohio Medical Products, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810290 is the FDA 510(k) clearance record for OHIO CAL-CHEK, a class I device, cleared for Ohio Medical Products on under FDA product code BXW (Calibrator, Volume, Gas). FDA records list 47 510(k) clearances for Ohio Medical Products, from to . As of , FDA records show no recalls naming K810290.

Clearance record

Decision date
Received
(9 days to decision)
Product code
BXW Calibrator, Volume, Gas
Regulation
21 CFR 868.1870
Device class
Class I
Review panel
Anesthesiology
Applicant
Ohio Medical Products 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BXW

Trailing 12 months

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

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