510(k) · Cleared
Recalled · Class II · 2018ABL8X7 Flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · CGL Electrode, Ion Based, Enzymatic, Creatinine
Cleared on Oct 16, 2006 as substantially equivalent to K041874 (Radiometer Medical Aps, 2004) and 3 other predicates after a 453-day review. Its family tree reaches back 6 generations to 1986. It has been recalled 4 times.
- Decided
- Oct 16, 2006
- Review
- 453 days
- Class
- Class II
- Product code
- CGL
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 6 generations to K861087 (1986). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 5 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 4 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 3 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 2 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 1 generation backK043218 ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 2005 · Recalled
- This deviceK051968 ABL8X7 FlexRadiometer Medical Aps · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −5 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −4 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −3 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −2 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −1 | K043218 | ABL800 Flex with Flexq Module, Model ABL8XX | Radiometer Medical Aps | 2005 | 3 |
| 0 (this device) | K051968 | ABL8X7 Flex | Radiometer Medical Aps | 2006 | — |
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 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 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 CGL? 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 CGL device
- #1 K261039 i-STAT Crea cartridge with the i-STAT 1 Systemscore 11.9 · 2 generations · no Class I recall
What was it cleared against? (4)
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…Analyzer Classification Name: Creatinine Test System (21 CFR Section 862.1225) Predicate Devices ABL800 FLEX (K041874), ABL800 FLEX with FLEXQ Module (K043218), ABL700 Series Upgrade (K002290) all by Radiometer Medical ApS and i-STAT System Creati… | 2004 |
| * | K043218 | ABL800 Flex with Flexq Module, Model ABL8XXSummary page 1…e: Creatinine Test System (21 CFR Section 862.1225) Predicate Devices ABL800 FLEX (K041874), ABL800 FLEX with FLEXQ Module (K043218), ABL700 Series Upgrade (K002290) all by Radiometer Medical ApS and i-STAT System Creatinine Test (K973292) by i-STAT. Device… | 2005 |
| * | K002290 | Abl-700 Series, Model Abl 7XX (Various Models)Summary page 1…tem (21 CFR Section 862.1225) Predicate Devices ABL800 FLEX (K041874), ABL800 FLEX with FLEXQ Module (K043218), ABL700 Series Upgrade (K002290) all by Radiometer Medical ApS and i-STAT System Creatinine Test (K973292) by i-STAT. Device Description The ABL837 FLEX is an… | 2000 |
| * | K973292 | I-Stat SystemSummary page 1…Devices ABL800 FLEX (K041874), ABL800 FLEX with FLEXQ Module (K043218), ABL700 Series Upgrade (K002290) all by Radiometer Medical ApS and i-STAT System Creatinine Test (K973292) by i-STAT. Device Description The ABL837 FLEX is an analyzer with the capability of measuring creatinine. The wet section of… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2018 | Class II | Z-0801-2019 | Under Investigation by firm | From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as… |
| Oct 29, 2014 | Class II | Z-1293-2015 | Under Investigation by firm | Negative drift on QC during in-use lifetime of CREA membranes can be observed. |
| Dec 16, 2011 | Not classified | Z-1008-2012 | Device Design | When the user activates the dosicap (containing the crea additive) and mounts it onto the bottle, the threads will not seal correctly causing approximately 10% of the solution to leak out when the bottle is placed horizontally for… |
| Mar 26, 2009 | Not classified | Z-1015-2010 | Other | Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 11 of the 18 ancestors have a recall of any class.
- 5 other devices also cite its predicate K041874.
How does its category compare?
All CGL devicesCGL Electrode, Ion Based, Enzymatic, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGL
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · CGL
Too few CGL 510(k)s in any year since 2007 to give a median.
Recalls per year · CGL
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGL
8in 2025
MAUDE reports naming product code CGL, 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 | — | 3 | 17 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 25 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ABL837 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood, plasma and serum for the parameter Creatinine. Creatinine measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051968: ABL8X7 Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051968
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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