510(k) · Cleared
ClearedABL90 FLEX PLUS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medicals Aps · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Dec 13, 2024 as substantially equivalent to K160153 (Radiometer Medical Aps, 2016) after a 246-day review. Its family tree reaches back 11 generations to 1986.
- Decided
- Dec 13, 2024
- Review
- 246 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K861087 (1986). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 7 generations between
- 3 generations backK122729 ABL90 FlexRadiometer Medical Aps · 2012
- 2 generations backK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
- 1 generation backK160153 ABL90 Flex PlusRadiometer Medical Aps · 2016 · Recalled
- This deviceK240998 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2024
Show all 11 generations
- Root · 11 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 10 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 9 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 8 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 7 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 6 generations backK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- 5 generations backK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- 4 generations backK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
- 3 generations backK122729 ABL90 FlexRadiometer Medical Aps · 2012
- 2 generations backK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
- 1 generation backK160153 ABL90 Flex PlusRadiometer Medical Aps · 2016 · Recalled
- This deviceK240998 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −10 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −9 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −8 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −7 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −6 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| −5 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| −4 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
| −3 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
| −2 | K131988 | ABL90 Flex Analyzer | Radiometer Medical Aps | 2013 | — |
| −1 | K160153 | ABL90 Flex Plus | Radiometer Medical Aps | 2016 | 5 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K160153 | ABL90 Flex PlusSummary page 5…Device Class: Class II Predicate Device Device Trade Name: ABL90 FLEX PLUS Common Name: Blood Gas Analyzer 510(k) K160153 Regulations: - 21 CFR 862.1120, Blood gases (pCO2, pO2) and blood pH test system… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 38 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 14 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K160153.
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. 2024, 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 System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (pO2), Oximetry (sO2, ctHb, FO2Hb, FCOHb, FMetHb, and FHHb), in heparinized arterial and venous whole blood. The ABL90 FLEX PLUS System 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…
Read the full statement (178 words)
The ABL90 FLEX PLUS System is an in vitro diagnostic, portable, automated analyzer that quantitatively measures pH, blood gas (pO2), Oximetry (sO2, ctHb, FO2Hb, FCOHb, FMetHb, and FHHb), in heparinized arterial and venous whole blood.
The ABL90 FLEX PLUS System 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 and pO2: pH and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
ctHb (Total Hemoglobin): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240998 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240998: ABL90 FLEX PLUS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240998
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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