# K240998: ABL90 FLEX PLUS System

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medicals Aps
- Decided: Dec 13, 2024 after 246 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 pH, blood gas (pO2), Oximetry (sO2, ctHb, FO2Hb, FCOHb, FMetHb, and FHHb), in heparinized arterial and venous 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 pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances. sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin. ctHb (Total Hemoglobin): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. FO2Hb: Oxyhemoglobin as a fraction of total hemoglobin. FCOHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. FMetHb: Methemoglobin as a fraction of total hemoglobin. FHHb: Reduced hemoglobin as a fraction of total hemoglobin.

Source page: https://510kreport.com/device/K240998
Methodology: https://510kreport.com/methodology