510(k) · Cleared
Recalled · Class II · 2013ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer America, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Feb 9, 1998 as substantially equivalent to K962334 (Radiometer America, Inc., 1996) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1995. 44 later devices descend from it. It has been recalled 5 times.
- Decided
- Feb 9, 1998
- Review
- 26 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K952621 (1995). 4 ancestors in all, the oldest K914166 (1992). 44 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK952621 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1995
- 1 generation backK962334 EML105 Electrolyte Metabolite AnalyzerRadiometer America, Inc. · 1996 · Recalled
- This deviceK980130 ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemRadiometer America, Inc. · 1998
- Descendant · cites it directly · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 3 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · cites it directly · 16 of its ownK991417 Abl 735 AnalyzerRadiometer America, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · cites it directly31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 2 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 3 generations on18descendants
- K991417Abl 735 AnalyzerRadiometer America, Inc. · 1999 · cites it directly16descendants
- K092686ABL90 Flex SeriesRadiometer Medical Aps · 2010 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952621 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1995 | — |
| −1 | K962334 | EML105 Electrolyte Metabolite Analyzer | Radiometer America, Inc. | 1996 | 1 |
| 0 (this device) | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System | Radiometer America, Inc. | 1998 | — |
| +1 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +2 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +3 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +1 | K991417 | Abl 735 Analyzer | Radiometer America, Inc. | 1999 | 2 |
| +3 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 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 14.1 · 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 |
|---|---|---|---|
| * | K962334 | EML105 Electrolyte Metabolite AnalyzerSummary page 1…nologically similar to the ABL625 and ABL555. SUBSTANTIAL EQUIVALENCE: ABL700 Series is substantially equivalent in features and characteristics to the current ABL625 (K962334) and ABL555 (K973367) marketed by Radiometer America Inc. WIALTY of ., W SEVICES T %, (7 DEPARTMENT OF HEALTH… | 1996 |
| * | K973367 | ABL555 Blood Gas, Electrolyte & Metabolite SystemSummary page 1…o the ABL625 and ABL555. SUBSTANTIAL EQUIVALENCE: ABL700 Series is substantially equivalent in features and characteristics to the current ABL625 (K962334) and ABL555 (K973367) marketed by Radiometer America Inc. WIALTY of ., W SEVICES T %, (7 DEPARTMENT OF HEALTH & HUMAN SERVICES Pub… | 1997 |
What descends from it? (44)
See all 444 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 |
|---|---|---|---|---|
| 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. |
| Apr 7, 2011 | Not classified | Z-2571-2011 | Pending | Based on internal testing and user/customer complaint reports received, the firm determined that wrinkles may arise on the outer membrane of the calcium membrane units upon installation. Retention of fluids between the wrinkles can cause… |
| 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… |
| Sep 19, 2005 | Not classified | Z-1323-06 | Other | Reference electrodes for the firm's ABL 700/800 Blood Gas Analyzers are oversized and will not fit into the instrument. |
| Feb 1, 2005 | Not classified | Z-1314-06 | Other | The CI membrane units generate too low values for status and sensitivity during calibration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K992859 (Radiometer America, Inc., 2000) has gone furthest, with 31 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 | — |
What is it indicated for?
ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO,, pO, , cNa*, cK*, cCa**, cCL’, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO, and pCO, on expired air.
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/K980130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980130: ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980130
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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