510(k) · Cleared
Recalled · Class II · 2012ABL700 Series Analyzer with Autocheck Module
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 Jan 10, 2000 as substantially equivalent to K980130 (Radiometer America, Inc., 1998) and 2 other predicates after a 138-day review. Its family tree reaches back 3 generations to 1986. 31 later devices descend from it. It has been recalled 4 times.
- Decided
- Jan 10, 2000
- Review
- 138 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 3 generations to K861087 (1986). 13 ancestors in all. 31 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 2 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 1 generation backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- This deviceK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 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 · 2 generations on · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- Descendant · 3 generations on · 6 of its ownK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
- Descendant · 4 generations on · 5 of its ownK122729 ABL90 FlexRadiometer Medical Aps · 2012
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · 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 · 2 generations on12descendants
- K120197ABL90 FlexRadiometer Medical Aps · 2012 · 3 generations on6descendants
- K122729ABL90 FlexRadiometer Medical Aps · 2012 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −2 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −1 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| 0 (this device) | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | — |
| +1 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +2 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +2 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| +3 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
| +4 | K122729 | ABL90 Flex | Radiometer Medical Aps | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 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 14.1 · 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? (3)
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 |
|---|---|---|---|
| * | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemSummary page 1…toCheck Module Common Name: pH/Blood Gas/Co-oximetry/Electrolyte/Metabolyte Analyzer Classification Name: Blood Gas and Blood pH Test System RADIOMETER ABL700 Series (K980130, RADIOMETER Qualicheck 5+ (K980135) and AVL9181 Electrolyte Analyzer (K972673). The ABL700 Series Analyzer with the AutoCheck mo… | 1998 |
| * | K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760Summary page 1…od Gas/Co-oximetry/Electrolyte/Metabolyte Analyzer Classification Name: Blood Gas and Blood pH Test System RADIOMETER ABL700 Series (K980130, RADIOMETER Qualicheck 5+ (K980135) and AVL9181 Electrolyte Analyzer (K972673). The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the… | 1998 |
| * | K972673 | Avl 9181 Electrolyte AnalyzerSummary page 1…nalyzer Classification Name: Blood Gas and Blood pH Test System RADIOMETER ABL700 Series (K980130, RADIOMETER Qualicheck 5+ (K980135) and AVL9181 Electrolyte Analyzer (K972673). The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the added capability of performing automated a… | 1997 |
What descends from it? (31)
See all 312 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, 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… |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 13 ancestors have a recall of any class.
- Of its descendants, K041874 (Radiometer Medical Aps, 2004) has gone furthest, with 29 descendants of its own.
- 3 other devices also cite its predicate K980130.
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 ABL700 Series Analyzer with the AutoCheck module is a
stand-alone blood gas analyzer that measures pH, pCO,, pO,,
cNa®, cK*, cCa**, cCL", Glucose, Lactate, and Co-oximetry
parameters on human artenal/venous and capillary whole blood.
The AutoCheck Module is an added functionality to perform
automated analysis of quality control fluids.
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/K992859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992859: ABL700 Series Analyzer with Autocheck Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992859
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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