# K160153: ABL90 Flex Plus - Pathway: 510(k) (Special) - Applicant: Radiometer Medical Aps - Decided: Nov 4, 2016 after 287 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: 5 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 10 generations back to K861087 (1986). 23 ancestors in all. 2 later devices descend from it; 2 cite it directly. 0 of 26 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K132691: ABL90 Flex, Radiometer Medical Aps (2014) Summary page 9. - K131988: ABL90 Flex Analyzer, Radiometer Medical Aps (2013) Summary page 9. ## Most influential descendants - K252207: ABL90 FLEX PLUS System, safeCLINITUBES (2026), 0 descendants of its own - K240998: ABL90 FLEX PLUS System (2024), 0 descendants of its own ## Recalls of this device - Mar 21, 2025 · Class II · Z-1659-2025: ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer ceases to operate) during a sample measurement. The - Apr 14, 2021 · Class II · Z-1858-2021: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. - Apr 14, 2021 · Class II · Z-1857-2021: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed. - Feb 3, 2020 · Class II · Z-1761-2020: The firm received reports of occurrences where the barcode reader misinterpreted the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in c - Nov 21, 2019 · Class II · Z-2138-2020: The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the ## Indications for use The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood. The ABL90 FLEX PLUS analyzer 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. Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates. pH, pO2 and pCO2: pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid- base disturbances. Potassium (cK+): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Sodium (cNa+): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration,inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance. Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. Chloride (cCl–): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis. Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.) Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin. 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. Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically. Source page: https://510kreport.com/device/K160153 Methodology: https://510kreport.com/methodology