510(k) · Cleared
Recalled · Class II · 2012Abl-700 Series, Model Abl 7XX (Various Models)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical A/S · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Sep 13, 2000 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it. It has been recalled 9 times.
- Decided
- Sep 13, 2000
- Review
- 48 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 9
- Predicates
- 0
30 later devices descend from it, 3 citing it directly.
- This deviceK002290 Abl-700 Series, Model Abl 7XX (Various Models)Radiometer Medical A/S · 2000
- Descendant · cites it directly · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 2 generations on · 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
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K041874ABL800 FlexRadiometer Medical Aps · 2004 · cites it directly29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 2 generations on18descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002290 | Abl-700 Series, Model Abl 7XX (Various Models) | Radiometer Medical A/S | 2000 | — |
| +1 | 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 |
| +2 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
| +3 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (30)
See all 303 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 |
|---|---|---|---|---|
| Oct 8, 2012 | Class II | Z-2303-2013 | Process control | RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane. |
| 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. |
| Sep 5, 2008 | Not classified | Z-0457-2009 | Process control | The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these… |
| Jan 18, 2008 | Not classified | Z-1653-2008 | 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… |
| Nov 13, 2006 | Not classified | Z-1094-2007 | 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… |
| Sep 29, 2005 | Not classified | Z-1386-06 | 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… |
| Jun 17, 2005 | Not classified | Z-1317-06 | 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. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041874 (Radiometer Medical Aps, 2004) has gone furthest, with 29 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.
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 | — |
https://510kreport.com/device/K002290 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002290: Abl-700 Series, Model Abl 7XX (Various Models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002290
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026