510(k) · Cleared
Recalled · Class II · 2018ABL90 Flex
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 Mar 19, 2012 as substantially equivalent to K092686 (Radiometer Medical Aps, 2010) after a 56-day review. Its family tree reaches back 7 generations to 1986. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 19, 2012
- Review
- 56 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 7 generations to K861087 (1986). 19 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 6 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 5 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 4 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 3 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 2 generations backK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- 1 generation backK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- This deviceK120197 ABL90 FlexRadiometer Medical Aps · 2012
- Descendant · cites it directly · 5 of its ownK122729 ABL90 FlexRadiometer Medical Aps · 2012
- Descendant · 2 generations on · 3 of its ownK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
- Descendant · 3 generations on · 2 of its ownK160153 ABL90 Flex PlusRadiometer Medical Aps · 2016 · Recalled
- Descendant · 4 generations on · 0 of its ownK252207 ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps · 2026
- Descendant · 4 generations on · 0 of its ownK240998 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122729ABL90 FlexRadiometer Medical Aps · 2012 · cites it directly5descendants
- K131988ABL90 Flex AnalyzerRadiometer Medical Aps · 2013 · 2 generations on3descendants
- K160153ABL90 Flex PlusRadiometer Medical Aps · 2016 · 3 generations on2descendants
- K252207ABL90 FLEX PLUS System, safeCLINITUBESRadiometer Medicals Aps · 2026 · 4 generations on0descendants
- K240998ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −6 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −5 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −4 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −2 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| −1 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| 0 (this device) | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
| +1 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
| +2 | K131988 | ABL90 Flex Analyzer | Radiometer Medical Aps | 2013 | — |
| +3 | K160153 | ABL90 Flex Plus | Radiometer Medical Aps | 2016 | 5 |
| +4 | K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | 2026 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K092686 | ABL90 Flex SeriesSummary page 1…op T" is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate: 510(k) Number/Device Manufacturer: K092686 ABL90 Flex, Radiometer Medical ApS Page of 2Page 15… | 2010 |
What descends from it? (6)
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 |
|---|---|---|---|---|
| May 25, 2018 | Class II | Z-0010-2019 | Device Design | The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: The analyzer is in ready mode Operator lifts the inlet and then closes it again, thereby initiating a rinse Immediately after lifts the… |
| Dec 8, 2014 | Class II | Z-1046-2015 | Software design | The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result. |
| Jul 5, 2012 | Class II | Z-2164-2012 | Software design | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 12 of the 19 ancestors have a recall of any class.
- Of its descendants, K122729 (Radiometer Medical Aps, 2012) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K092686.
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. 2012, 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 is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood. The ABL9O 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, p02 and pCO2: pH, pCO2 and p02 measurements are used in…
Read the full statement (354 words)
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood. The ABL9O 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, p02 and pCO2: pH, pCO2 and p02 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 (cCa 2 +): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride (cCF-): 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.
FO 2 Hb: oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemnoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: methemoglobin as a fraction of total hemoglobin.
EHI-b: 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 as stated in the FDA summary.
https://510kreport.com/device/K120197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120197: ABL90 Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120197
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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