510(k) · Cleared
Recalled · 2006Modification to ABL800 Flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · CIG Diazo Colorimetry, Bilirubin
Cleared on Aug 11, 2005 as substantially equivalent to K041874 (Radiometer Medical Aps, 2004) after a 127-day review. Its family tree reaches back 5 generations to 1986. 18 later devices descend from it. It has been recalled once.
- Decided
- Aug 11, 2005
- Review
- 127 days
- Class
- Class II
- Product code
- CIG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K861087 (1986). 16 ancestors in all. 18 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 4 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 3 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 2 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 1 generation backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- This deviceK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005
- 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 · 3 of its ownK132691 ABL90 FlexRadiometer Medical Aps · 2014
- Descendant · 4 generations on · 3 of its ownK131988 ABL90 Flex AnalyzerRadiometer Medical Aps · 2013
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- 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
- K132691ABL90 FlexRadiometer Medical Aps · 2014 · cites it directly3descendants
- K131988ABL90 Flex AnalyzerRadiometer Medical Aps · 2013 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −4 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −3 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −2 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −1 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| 0 (this device) | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | — |
| +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 | K132691 | ABL90 Flex | Radiometer Medical Aps | 2014 | — |
| +4 | K131988 | ABL90 Flex Analyzer | Radiometer Medical Aps | 2013 | — |
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 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 CIG? 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 CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 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 |
|---|---|---|---|
| * | K041874 | ABL800 FlexSummary page 1…Kos50 q 510(k) Summary As required by 807.92 For RADIANCE v2.5 modification to ABL800 FLEX (K041874) Prepared on March 30, 2005 Submitted by: Radiometer Medical ApS Akandevej 21… | 2004 |
What descends from it? (18)
See all 184 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 6, 2006 | Not classified | Z-0115-2007 | Other | Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 9 of the 16 ancestors have a recall of any class.
- Of its descendants, K092686 (Radiometer Medical Aps, 2010) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K041874.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, 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 | — | 0 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Indications: The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, P02.pCO 2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters p02 and pCO 2. The ABL800 FLEX with RADIANCE v2.5 modification 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/K050869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050869: Modification to ABL800 Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050869
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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