510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K954612Substantially Equivalent

Abl System 625, 615, 605

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

K954612 is the FDA 510(k) clearance record for ABL SYSTEM 625, 615, 605, a class II device, cleared for Radiometer America, Inc. on under FDA product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph). FDA records list 50 510(k) clearances for Radiometer America, Inc., from to . As of , FDA records show one recall naming K954612.

Clearance record

Decision date
Received
(35 days to decision)
Product code
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Regulation
21 CFR 862.1120
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Radiometer America, Inc. 810 Sharon Dr., Westlake OH
510(k) summary
Summary
Third party review
No

Clearances, product code CHL

Trailing 12 months
1 clearance under product code CHL in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260