# K252207: ABL90 FLEX PLUS System, safeCLINITUBES

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medicals Aps
- Decided: Apr 10, 2026 after 270 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K861087 (1986). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160153: ABL90 Flex Plus, Radiometer Medical Aps (2016) Summary page 5.

## Indications for use
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures: -blood gas (pCO2) in heparinized arterial, venous and capillary whole blood, and -pH and oximetry (ctHb) in heparinized capillary whole blood. The ABL90 FLEX PLUS System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient, or point-of-care setting. These tests are only performed under a physician's order. pH and pCO2: pH and pCO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. ctHb (Total Hemoglobin): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia in venous and arterial whole blood. Capillary whole blood is used to estimate the presence of ctHb. safeCLINITUBES are intended for the collection, mixing, and dispensing of capillary whole blood samples on the ABL90 FLEX PLUS System.

Source page: https://510kreport.com/device/K252207
Methodology: https://510kreport.com/methodology