510(k) · Cleared
Recalled · Class II · 2012ABL800 Flex with Flexq Module, Model ABL8XX
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 May 10, 2005 as substantially equivalent to K041874 (Radiometer Medical Aps, 2004) and 1 other predicate after a 169-day review. Its family tree reaches back 5 generations to 1986. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- May 10, 2005
- Review
- 169 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 5 generations to K861087 (1986). 16 ancestors in all. 4 later devices descend from it, 3 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 deviceK043218 ABL800 Flex with Flexq Module, Model ABL8XXRadiometer Medical Aps · 2005
- Descendant · cites it directly · 1 of its ownK073537 Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK151639 ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK110277 Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK051968 ABL8X7 FlexRadiometer Medical Aps · 2006 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K073537Neonatal Bilirubin on Rapidlab Models 1245 and 1265Siemens Medical Solutions Diagnostics · 2008 · cites it directly1descendant
- K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc. · 2015 · cites it directly0descendants
- K110277Rapidpoint 405 Neonatal BilirubinSiemens Healthcare Diagnostics · 2011 · 2 generations on0descendants
- K051968ABL8X7 FlexRadiometer Medical Aps · 2006 · cites it directly0descendants
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) | K043218 | ABL800 Flex with Flexq Module, Model ABL8XX | Radiometer Medical Aps | 2005 | — |
| +1 | K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265 | Siemens Medical Solutions Diagnostics | 2008 | 7 |
| +1 | K151639 | ABL80 FLEX and ABL80 FLEX CO-OX | Sendx Medical, Inc. | 2015 | — |
| +2 | K110277 | Rapidpoint 405 Neonatal Bilirubin | Siemens Healthcare Diagnostics | 2011 | 5 |
| +1 | K051968 | ABL8X7 Flex | Radiometer Medical Aps | 2006 | 4 |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 14.2 · 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 |
|---|---|---|---|
| * | K041874 | ABL800 FlexSummary page 1…Classification Name: Blood gases and blood pH test system (21 CFR Section 862.1120) Predicate Devices RADIOMETER ABL800 FLEX (K041874) and AVL 9181 Electrolyte Analyzer (K972673). Device Description The ABL800 FLEX with FLEXO Module is an ABL800 FLEX Analyzer w… | 2004 |
| * | K972673 | Avl 9181 Electrolyte AnalyzerSummary page 1…and blood pH test system (21 CFR Section 862.1120) Predicate Devices RADIOMETER ABL800 FLEX (K041874) and AVL 9181 Electrolyte Analyzer (K972673). Device Description The ABL800 FLEX with FLEXO Module is an ABL800 FLEX Analyzer with the added optional capability of automat… | 1997 |
What descends from it? (4)
3 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 |
|---|---|---|---|---|
| Oct 8, 2012 | Class II | Z-2303-2013 | Process control | RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane. |
| 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… |
| Jan 16, 2007 | Not classified | Z-0705-2007 | Other | In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by… |
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, K073537 (Siemens Medical Solutions Diagnostics, 2008) has gone furthest, with 1 descendant 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.
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 with FLEXQ Module is intended for in vitro testing of samples of whole blood for the parameters pH, P0 2, pCO 2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) as well as for in vitro testing of samples of expired air for the parameters PO2 and pCO 2. Indication for use information…
Read the full statement (463 words)
The ABL800 FLEX with FLEXQ Module is intended for in vitro testing of samples of whole blood for the parameters pH, P0 2, pCO 2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) as well as for in vitro testing of samples of expired air for the parameters PO2 and pCO 2.
Indication for use information for the analytes measured by the ABL800 FLEX:
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.
PC0 2: pCO 2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK4): 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 2 l): The measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cClj: 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.
Blifrubin (ctBiI): 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 (sO 2): 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): FCOI-b 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 consists of two a-chains and two P-chains, and has a higher oxygen affinity than adult Hb.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043218 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043218: ABL800 Flex with Flexq Module, Model ABL8XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043218
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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