# K092686: ABL90 Flex Series

- Pathway: 510(k) (Traditional)
- Applicant: Radiometer Medical Aps
- Decided: Aug 6, 2010 after 338 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K861087 (1986). 18 ancestors in all.
12 later devices descend from it; 6 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050869: Modification to ABL800 Flex, Radiometer Medical Aps (2005) Summary page 2.
- K041874: ABL800 Flex, Radiometer Medical Aps (2004) Summary page 2.
- K002290: Abl-700 Series, Model Abl 7XX (Various Models), Radiometer Medical A/S (2000) Summary page 2.
- K982928: NPT7 Series PH/Blood Gas and CO-Oximetry System, Radiometer America, Inc. (1999) Summary page 2.
- K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760, Radiometer America, Inc. (1998) Summary page 2.

## Cited in the summary but kept off the family tree
- K083370: D-Clot Thrombectomy Catheter System, Model: DC 4006, Artegraft, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K120197: ABL90 Flex (2012), 6 descendants of its own
- K122729: ABL90 Flex (2012), 5 descendants of its own
- K131988: ABL90 Flex Analyzer (2013), 3 descendants of its own
- K160153: ABL90 Flex Plus (2016), 2 descendants of its own
- K111897: ABL90 (2011), 1 descendant 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-1856-2021: Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
- Feb 3, 2020 · Class II · Z-1760-2020: 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-2139-2020: 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 
- Jul 10, 2019 · Class II · Z-2320-2019: Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in d
- Jan 26, 2017 · Class II · Z-1462-2017: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
- Oct 15, 2013 · Class II · Z-0816-2014: RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
- Jan 12, 2011 · Not classified · Z-2112-2011: Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their ABL 90 Analyzer does not prevent the further use of the sensor cassette
- Nov 1, 2010 · Not classified · Z-1011-2011: Due to a software error, a patient mix up can occur on the ABL90. If a sample is pre-registered and the sample "fails" the next result will inherit the patient data from the previous result.

## Indications for use
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood. The ABL90 FLEX 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, 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): FHDF indicates the amount of fetal hemogiobin. FHUF is seldom used clinically.

Source page: https://510kreport.com/device/K092686
Methodology: https://510kreport.com/methodology