510(k) · Cleared
Recalled · Class II · 2026ABL800 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 Oct 8, 2004 as substantially equivalent to K002290 (Radiometer Medical A/S, 2000) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1986. 29 later devices descend from it. It has been recalled 22 times.
- Decided
- Oct 8, 2004
- Review
- 88 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 22
- Predicates
- 2
Its longest line of descent runs back 4 generations to K861087 (1986). 15 ancestors in all. 29 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 3 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 2 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 1 generation backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- This deviceK041874 ABL800 FlexRadiometer Medical Aps · 2004
- Descendant · cites it directly · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · cites it directly · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- Descendant · 2 generations on · 6 of its ownK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK122729 ABL90 FlexRadiometer Medical Aps · 2012
- Descendant · cites it directly · 4 of its ownK043218 ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 2005 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · cites it directly18descendants
- K092686ABL90 Flex SeriesRadiometer Medical Aps · 2010 · cites it directly12descendants
- K120197ABL90 FlexRadiometer Medical Aps · 2012 · 2 generations on6descendants
- K122729ABL90 FlexRadiometer Medical Aps · 2012 · 3 generations on5descendants
- K043218ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 2005 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −3 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −2 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −1 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| 0 (this device) | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | — |
| +1 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +1 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| +2 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
| +3 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
| +1 | K043218 | ABL800 Flex with Flexq Module, Model ABL8XX | Radiometer Medical Aps | 2005 | 3 |
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 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K002290 | Abl-700 Series, Model Abl 7XX (Various Models)Summary page 1…bolite Analyzer Classification Name: Blood gases and blood pH test system Predicate Devices RADIOMETER ABL700 Series Upgrade (K002290) and ABL700 with AutoCheck Module (K992859). Device Description The ABL800 FLEX is an automatic analyzer for in vitro testing o… | 2000 |
| * | K992859 | ABL700 Series Analyzer with Autocheck ModuleSummary page 1…zer Classification Name: Blood gases and blood pH test system Predicate Devices RADIOMETER ABL700 Series Upgrade (K002290) and ABL700 with AutoCheck Module (K992859). Device Description The ABL800 FLEX is an automatic analyzer for in vitro testing of blood gases, electrolytes, metabolites an… | 2000 |
What descends from it? (29)
See all 296 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 |
|---|---|---|---|---|
| Aug 18, 2026 | Class II | Z-0190-2027 | No Marketing Application | In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges… |
| May 31, 2024 | Class II | Z-2426-2024 | Nonconforming Material/Component | Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased… |
| May 18, 2022 | Class II | Z-1321-2022 | Software design | There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. |
| May 26, 2020 | Class II | Z-2494-2020 | Software design | Potential risk of patient mix-up on analyzers due to software issues. |
| May 26, 2020 | Class II | Z-2493-2020 | Software design | Potential risk of patient mix-up on analyzers due to software issues. |
| Mar 10, 2020 | Class II | Z-1684-2020 | Software design | Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample… |
| Mar 6, 2020 | Class II | Z-1836-2020 | Component design/selection | Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay… |
| Jul 3, 2018 | Class II | Z-0682-2019 | Software design | The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. |
| Oct 24, 2017 | Class II | Z-0231-2018 | Software in the Use Environment | Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer. |
| Jan 26, 2017 | Class II | Z-1463-2017 | Device Design | Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous. |
| Jul 5, 2013 | Class II | Z-1075-2014 | Under Investigation by firm | RADIOMETER has become aware that some D788 pCO2 membranes can cause biased measurement results on patient results as well as QC results. |
| Jul 5, 2012 | Class II | Z-2163-2012 | 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… |
| Jul 5, 2012 | Class II | Z-2162-2012 | 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… |
| Apr 16, 2009 | Not classified | Z-1554-2009 | Process design | When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle. |
| Jan 18, 2008 | Not classified | Z-1654-2008 | Software design | Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and… |
| Jun 22, 2007 | Not classified | Z-0038-2008 | Process design | Tube may break. The firm discovered that the yellowish/white tubes used in their blood gas analyzers (ABL800 Flex Series) were manufactured incorrectly. These tubes have the potential to break off at the black plastic connectors. The… |
| Nov 13, 2006 | Not classified | Z-1095-2007 | Software design | Software anomaly. Protein removing program incorporated in the operating software for Versions: V3.833 and V5.24, of the ABL700 and ABL800 Blood Gas Analyzers, may allow for protein build up on the electrode membranes of blood gas… |
| Oct 31, 2005 | Not classified | Z-1325-06 | Other | ABL800 Series Blood Gas Analyzer became inoperable when the 'restore default setup' button was touched. |
| Sep 29, 2005 | Not classified | Z-1387-06 | Other | Under certain circumstances, the ABL 700 &800 Series Blood Gas Analyzers may experience leakage current into the measuring system. Consequently, the analyzers intermittently provide incorrect (too low) result values for Calcium (Ca) and… |
| Sep 19, 2005 | Not classified | Z-1324-06 | Other | Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument. |
| Jun 17, 2005 | Not classified | Z-1318-06 | Other | Software defect. pO2 and pCO2 sample test results run on the firm's ABL700/800 Series Blood Gas Analyzers are not being properly flagged during the sample calibration phase. |
| Jun 17, 2005 | Not classified | Z-1319-06 | Other | The recalled membranes cause the status value of the pH and electrolyte electrodes to be offset causing readings outside of the acceptable range. |
The 5 latest of 22 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 18 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 8 of the 15 ancestors have a recall of any class.
- Of its descendants, K050869 (Radiometer Medical Aps, 2005) has gone furthest, with 18 descendants of its own.
- 2 other devices also cite its predicate K002290.
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.
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 ABL800 FLEX is intended for in vitro testing of samples of whole blood for the parameters pH, PO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for in vitro testing of samples of expired air for the parameters PO2 and PCO2. The ABL800 FLEX includes an AutoCheck Module to perform automated analysis of quality control fluids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041874 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041874: ABL800 Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041874
Report an extraction error
Are you the manufacturer?
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