510(k) · Cleared
Recalled · Class II · 2025ABL90 Flex Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Nov 4, 2016 as substantially equivalent to K132691 (Radiometer Medical Aps, 2014) and 1 other predicate after a 287-day review. Its family tree reaches back 10 generations to 1986. 2 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 4, 2016
- Review
- 287 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 10 generations to K861087 (1986). 23 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 6 generations between
- 3 generations backK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
- 2 generations backK122729 ABL90 FlexRadiometer Medical Aps · 2012
- 1 generation backK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
- This deviceK160153 ABL90 Flex PlusRadiometer Medical Aps · 2016
- Descendant · cites it directly · 0 of its ownK252207 ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps · 2026
- Descendant · cites it directly · 0 of its ownK240998 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2024
Show all 10 generations
- Root · 10 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 9 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 8 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 7 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 6 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 5 generations backK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- 4 generations backK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- 3 generations backK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
- 2 generations backK122729 ABL90 FlexRadiometer Medical Aps · 2012
- 1 generation backK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
- This deviceK160153 ABL90 Flex PlusRadiometer Medical Aps · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −9 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −8 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −7 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −6 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −5 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| −4 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| −3 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
| −2 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
| −1 | K131988 | ABL90 Flex Analyzer | Radiometer Medical Aps | 2013 | — |
| 0 (this device) | K160153 | ABL90 Flex Plus | Radiometer Medical Aps | 2016 | — |
| +1 | K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | 2026 | — |
| +1 | K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2024 | — |
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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 CHL? 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 CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132691 | ABL90 FlexSummary page 9…amount of fetal hemoglobin. FHbF is seldom used clinically. Page 4 of 12 4. Predicate device: ABL90 FLEX (K132691) Substantial Equivalence The ABL90 FLEX PLUS analyzer is substantially equivalent in Intended Use, fundamental scientific technol… | 2014 |
| * | K131988 | ABL90 Flex AnalyzerSummary page 9…hnology, features, and characteristics to the predicate devices: Predicate Device: 510(k) Number, Name, Device Manufacturer: K132691, ABL90 FLEX, Radiometer Medical ApS K131988, ABL90 FLEX, Radiometer Medical ApS Similarities Issue SE Devic… | 2013 |
What descends from it? (2)
2 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-1857-2021 | 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-1761-2020 | 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-2138-2020 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 13 of the 23 ancestors have a recall of any class.
- Of its descendants, K252207 (Radiometer Medicals Aps, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, 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 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
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…
Read the full statement (385 words)
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.
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/K160153 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160153: ABL90 Flex Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160153
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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