510(k) · Cleared
Recalled · Class II · 2025ABL90 Flex Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · CEM Electrode, Ion Specific, Potassium
Cleared on Aug 6, 2010 as substantially equivalent to K050869 (Radiometer Medical Aps, 2005) and 4 other predicates after a 338-day review. Its family tree reaches back 6 generations to 1986. 12 later devices descend from it. It has been recalled 10 times.
- Decided
- Aug 6, 2010
- Review
- 338 days
- Class
- Class II
- Product code
- CEM
- Recalls
- 10
- Predicates
- 6
Its longest line of descent runs back 6 generations to K861087 (1986). 18 ancestors in all. 12 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 5 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 4 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 3 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 2 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 1 generation backK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- This deviceK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010
- Descendant · cites it directly · 6 of its ownK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
- Descendant · 2 generations on · 5 of its ownK122729 ABL90 FlexRadiometer Medical Aps · 2012
- Descendant · 3 generations on · 3 of its ownK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
- Descendant · 4 generations on · 2 of its ownK160153 ABL90 Flex PlusRadiometer Medical Aps · 2016 · Recalled
- Descendant · cites it directly · 1 of its ownK111897 ABL90Radiometer Medical Aps · 2011 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K120197ABL90 FlexRadiometer Medical Aps · 2012 · cites it directly6descendants
- K122729ABL90 FlexRadiometer Medical Aps · 2012 · 2 generations on5descendants
- K131988ABL90 Flex AnalyzerRadiometer Medical Aps · 2013 · 3 generations on3descendants
- K160153ABL90 Flex PlusRadiometer Medical Aps · 2016 · 4 generations on2descendants
- K111897ABL90Radiometer Medical Aps · 2011 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −5 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −4 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −3 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −2 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −1 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| 0 (this device) | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | — |
| +1 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
| +2 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
| +3 | K131988 | ABL90 Flex Analyzer | Radiometer Medical Aps | 2013 | — |
| +4 | K160153 | ABL90 Flex Plus | Radiometer Medical Aps | 2016 | 5 |
| +1 | K111897 | ABL90 | Radiometer Medical Aps | 2011 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CEM device
- #1 K253491 ISE indirect K for Gen.2; ISE indirect Na for…score 11.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K083370 | FDA’s K083370 is D-Clot Thrombectomy Catheter System, Model: DC 4006 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
| * | K050869 | Modification to ABL800 FlexSummary page 2…tes: the ABLBO FLEX Co-Ox, the ABL80O FLEX, the ABL735, the NPT7 and the QUALICHECKS®. 210(k) Number/Device Manufacturer: K08370 ABL80 FLEX Co-OX, SenDx Medical, Inc. . K050869 Modification to ABL800 FLEX, Radiometer Medical ApS K041874 ABLB0O FLEX, Radiometer Medical ApS K002290 ABL735 Series, Radiomete… | 2005 |
| * | K041874 | ABL800 FlexSummary page 2…NPT7 and the QUALICHECKS®. 210(k) Number/Device Manufacturer: K08370 ABL80 FLEX Co-OX, SenDx Medical, Inc. . K050869 Modification to ABL800 FLEX, Radiometer Medical ApS K041874 ABLB0O FLEX, Radiometer Medical ApS K002290 ABL735 Series, Radiometer Medical A/S K982928 NPT7, Radiometer America Inc. K98013… | 2004 |
| * | K002290 | Abl-700 Series, Model Abl 7XX (Various Models)Summary page 2…ice Manufacturer: K08370 ABL80 FLEX Co-OX, SenDx Medical, Inc. . K050869 Modification to ABL800 FLEX, Radiometer Medical ApS K041874 ABLB0O FLEX, Radiometer Medical ApS K002290 ABL735 Series, Radiometer Medical A/S K982928 NPT7, Radiometer America Inc. K980135 QUALICHECKS*, Radiometer America Inc. With… | 2000 |
| * | K982928 | NPT7 Series PH/Blood Gas and CO-Oximetry SystemSummary page 2…x Medical, Inc. . K050869 Modification to ABL800 FLEX, Radiometer Medical ApS K041874 ABLB0O FLEX, Radiometer Medical ApS K002290 ABL735 Series, Radiometer Medical A/S K982928 NPT7, Radiometer America Inc. K980135 QUALICHECKS*, Radiometer America Inc. With the ABL800 FLEX, ABL735 Series and the ABL90 F… | 1999 |
| * | K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760Summary page 2…to ABL800 FLEX, Radiometer Medical ApS K041874 ABLB0O FLEX, Radiometer Medical ApS K002290 ABL735 Series, Radiometer Medical A/S K982928 NPT7, Radiometer America Inc. K980135 QUALICHECKS*, Radiometer America Inc. With the ABL800 FLEX, ABL735 Series and the ABL90 FLEX, the principles of operation are si… | 1998 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2025 | Class II | Z-1659-2025 | Component design/selection | 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 analyzer software includes a feature… |
| Apr 14, 2021 | Class II | Z-1858-2021 | Device Design | 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 | Device Design | 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 | Software design | 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 connection with a sample measurement.… |
| Nov 21, 2019 | Class II | Z-2139-2020 | Nonconforming Material/Component | 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 received light has not been… |
| Jul 10, 2019 | Class II | Z-2320-2019 | Software design | 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 delayed medical treatment. |
| Jan 26, 2017 | Class II | Z-1462-2017 | Device Design | 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 | Other | 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 | Software design | 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 when there is the possibility of iron… |
| Nov 1, 2010 | Not classified | Z-1011-2011 | Software design | 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. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 11 of the 18 ancestors have a recall of any class.
- Of its descendants, K120197 (Radiometer Medical Aps, 2012) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K050869.
How does its category compare?
All CEM devicesCEM Electrode, Ion Specific, Potassium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CEM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CEM
180in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEM
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEM
29in 2025
MAUDE reports naming product code CEM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 66 |
| 2008 | 0 | — | 1 | 245 |
| 2009 | 1 | — | 0 | 79 |
| 2010 | 3 | 195 | 12 | 113 |
| 2011 | 3 | 74 | 6 | 126 |
| 2012 | 4 | 180 | 0 | 45 |
| 2013 | 0 | — | 0 | 37 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 32 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 1 | 25 |
| 2020 | 1 | — | 3 | 27 |
| 2021 | 0 | — | 1 | 18 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 2 | — | 2 | 30 |
| 2024 | 0 | — | 0 | 42 |
| 2025 | 1 | — | 4 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (350 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K092686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092686: ABL90 Flex Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092686
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026