510(k) · Cleared
Recalled · Class II · 2018ABL800 FLEX with AQURE connectivity
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Jun 17, 2015 as substantially equivalent to K041874 (Radiometer Medical Aps, 2004) after a 254-day review. Its family tree reaches back 5 generations to 1986. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 17, 2015
- Review
- 254 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K861087 (1986). 16 ancestors in all. 3 later devices descend from it, 1 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 deviceK142898 ABL800 FLEX with AQURE connectivityRadiometer Medical Aps · 2015
- Descendant · cites it directly · 2 of its ownK160402 GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total…Instrumentation Laboratory CO · 2016
- Descendant · 2 generations on · 1 of its ownK203790 GEM Premier 5000Instrumentation Laboratory CO · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK223608 GEM Premier 7000 with IQM3Instrumentation Laboratory Company · 2023 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K160402GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)Instrumentation Laboratory CO · 2016 · cites it directly2descendants
- K203790GEM Premier 5000Instrumentation Laboratory CO · 2021 · 2 generations on1descendant
- K223608GEM Premier 7000 with IQM3Instrumentation Laboratory Company · 2023 · 3 generations on0descendants
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) | K142898 | ABL800 FLEX with AQURE connectivity | Radiometer Medical Aps | 2015 | — |
| +1 | K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | Instrumentation Laboratory CO | 2016 | — |
| +2 | K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021 | 25 |
| +3 | K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023 | 2 |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 7…ntended Use, fundamental scientific technology, features, and characteristics to the predicate: 510(k) Number/Device Manufacturer: Radiometer Medical ApS. ABL800 FLEX - K041874 5. Registration history ABL800 FLEX was originally cleared with K041874, and then modified with the FLEXQ Module - an optional c… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160402 | GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) | 2016 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2018 | Class II | Z-1582-2018 | Device Design | There is a potential problem relating to the AQURE System, versions 2.3.0 and 2.3.1, that may result in patient mix-up. |
| Nov 23, 2016 | Class II | Z-0899-2017 | Software design | Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value. |
| Dec 29, 2015 | Class II | Z-0748-2016 | Device Design | The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results. The fact that the sample type field is left blank in some cases could lead to… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 9 of the 16 ancestors have a recall of any class.
- Of its descendants, K160402 (Instrumentation Laboratory CO, 2016) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K041874.
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. 2015, this device’s year, is highlighted.
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 ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters pO2 and pCO2, and for In vitro testing of pleura samples for the pH…
Read the full statement (535 words)
The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters pO2 and pCO2, and for In vitro testing of pleura samples for the pH parameter.
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.
pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK+): the measurements of the concentration of potassium ions in plasma are used to monitor the electrolyte balance.
Sodium (cNa+): the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The glucose measurements measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Bilirubin (ctBil): The bilirubin measurements measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.
Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the utilization of the potential oxygen transport capacity; that is the fraction of oxyhemoglobin in relation to all hemoglobins present (tHb) including dyshemoglobins.
Fraction of Carboxyhemoglobin (FCOHb): FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two α-chains and two β-chains, and has a higher oxygen affinity than adult Hb.
Creatinine (cCrea): The 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.
Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of <7.3 are referred as complicated parapneumonic effusions; they are exudative in nature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142898: ABL800 FLEX with AQURE connectivity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142898
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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