510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840452Substantially Equivalent

Premium Dabm Dispos. Anes. Breath Mask

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

K840452 is the FDA 510(k) clearance record for PREMIUM DABM DISPOS. ANES. BREATH MASK, a class I device, cleared for Ohio Medical Products on under FDA product code BSJ (Mask, Gas, Anesthetic). FDA records list 47 510(k) clearances for Ohio Medical Products, from to . As of , FDA records show no recalls naming K840452.

Clearance record

Decision date
Received
(16 days to decision)
Product code
BSJ Mask, Gas, Anesthetic
Regulation
21 CFR 868.5550
Device class
Class I
Review panel
Anesthesiology
Applicant
Ohio Medical Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BSJ

Trailing 12 months

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

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