510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910827Substantially Equivalent

Abl520 Blood Gas System

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

K910827 is the FDA 510(k) clearance record for ABL520 BLOOD GAS SYSTEM, a class II device, cleared for Radiometer America, Inc. on under FDA product code GHS (Assay, Carboxyhemoglobin). FDA records list 50 510(k) clearances for Radiometer America, Inc., from to . As of , FDA records show no recalls naming K910827.

Clearance record

Decision date
Received
(132 days to decision)
Product code
GHS Assay, Carboxyhemoglobin
Regulation
21 CFR 864.7425
Device class
Class II
Review panel
Hematology
Applicant
Radiometer America, Inc. 811 Sharon Dr., Westlake OH
Third party review
No

Clearances, product code GHS

Trailing 12 months

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

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