510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853990Substantially Equivalent

Osm3 Hemoximeter

Radiometer America, Inc, Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853990 is the FDA 510(k) clearance record for OSM3 HEMOXIMETER, a class I device, cleared for Radiometer America, Inc. on under FDA product code JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide). FDA records list 50 510(k) clearances for Radiometer America, Inc., from to . As of , FDA records show no recalls naming K853990.

Clearance record

Decision date
Received
(94 days to decision)
Product code
JKS Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Regulation
21 CFR 862.3220
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Radiometer America, Inc. 811 Sharon Dr., Westlake OH
Third party review
No

Clearances, product code JKS

Trailing 12 months

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

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