ABL90 FLEX PLUS System, safeCLINITUBES

FDA 510(k) K252207 · Radiometer Medicals Aps

Substantially Equivalent

510(k) numberK252207

Submission

Device name
ABL90 FLEX PLUS System, safeCLINITUBES
Applicant
Radiometer Medicals Aps
Brønshøj, DK
Received
July 14, 2025
Decision date
April 10, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1120
Specialty
Clinical Chemistry

Other 510(k)s with product code CHL

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K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional Abbott Point of Care, Inc.05/02/2025SE
K240998ABL90 FLEX PLUS SystemCHL · Traditional Radiometer Medicals Aps12/13/2024SE
K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional Abbott Point of Care, Inc.10/27/2023SE
K221900Stat Profile Prime Plus Analyzer SystemCHL · Traditional Nova Biomedical Corporation09/29/2023SE
K223857i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional Abbott Point of Care, Inc.09/15/2023SE
K223608GEM Premier 7000 with IQM3CHL · Traditional Instrumentation Laboratory Company08/10/2023SE
K211559EasyStat 300CHL · Traditional Medica Corporation01/27/2023SE
K203790GEM Premier 5000CHL · Special Instrumentation Laboratory CO08/20/2021SE
K200986OPTI® B-Lac CassetteCHL · Traditional Opti Medical Systems, Inc.08/02/2021SE
K200107epoc Blood Analysis SystemCHL · Special Epocal, Inc.06/05/2020SE

More from Epocal, Inc.

510(k)DeviceDecision
K252488ABL90 FLEX PLUS SystemCGA · Traditional 05/01/2026SE
K252475ABL90 FLEX PLUS SystemJGS · Traditional 05/01/2026SE
K241037ABL90 FLEX PLUS SystemCEM · Traditional 01/14/2025SE
K240998ABL90 FLEX PLUS SystemCHL · Traditional 12/13/2024SE

Questions and answers

When was ABL90 FLEX PLUS System, safeCLINITUBES cleared by the FDA?

ABL90 FLEX PLUS System, safeCLINITUBES (K252207) received a 510(k) decision of Substantially Equivalent on April 10, 2026, 270 days after the submission was received.

What is the product code of K252207?

The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.