510(k) · Cleared
Recalled · Class II · 2020ABL80 Flex Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sendx Medical, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Nov 1, 2005 as substantially equivalent to K994346 (Sendx Medical, Inc., 2000) and 2 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1986. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 1, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 6 generations to K861087 (1986). 18 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- 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 backK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- This deviceK051804 ABL80 Flex AnalyzerSendx Medical, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK080370 Abl 80 CO-OX SystemSendx Medical, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK151856 ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc. · 2015 · Recalled
Most influential descendants
Showing 2 of 2 · See allView 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 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| 0 (this device) | K051804 | ABL80 Flex Analyzer | Sendx Medical, Inc. | 2005 | — |
| +1 | K080370 | Abl 80 CO-OX System | Sendx Medical, Inc. | 2008 | 4 |
| +2 | K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | 2015 | 3 |
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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 14.1 · 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 |
|---|---|---|---|
| * | K994346 | Abl 77 PH, Blood Gas and Electrolyte Analysis SystemSummary page 2…urrently marketed SenDx and Radiometer Medical ApS blood analysis systems such as: 510(k) Number Device Manufacturer K994346 ABL77 SenDx Medical, Inc. K980130 ABL700 Family Radiom… | 2000 |
| * | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemSummary page 2…s such as: 510(k) Number Device Manufacturer K994346 ABL77 SenDx Medical, Inc. K980130 ABL700 Family Radiometer Medical ApS, Co… | 1998 |
| * | K050869 | Modification to ABL800 Flex Cleared while this submission was under review Summary page 2…K980130 ABL700 Family Radiometer Medical ApS, Copenhagen, Denmark K050869 RADIANCE v2.5 Radiometer Medical ApS, Modification to the Co… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080370 | Abl 80 CO-OX System | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 11, 2020 | Class II | Z-2467-2020 | Under Investigation by firm | Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or… |
| Jun 6, 2012 | Class II | Z-2304-2012 | Software design | The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition. |
| Jan 30, 2012 | Not classified | Z-1384-2012 | Nonconforming Material/Component | The product can cause the analyzer to report values outside the published performance specifications for pH, pCO2, cNa+, cK+, cCa2+ and cCl-. |
| Jun 4, 2007 | Not classified | Z-1201-2007 | Other | The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 11 of the 18 ancestors have a recall of any class.
- Of its descendants, K080370 (Sendx Medical, Inc., 2008) has gone furthest, with 1 descendant of its own.
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?
These tests are only performed under a physicians order: pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/Blood gas measurement. p02: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs. pCO 2: pCO 2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate. Potassium (cK+): The potassium level is the predominant intracellular cation.…
Read the full statement (221 words)
These tests are only performed under a physicians order:
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/Blood gas measurement.
p02: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO 2: pCO 2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK+): The potassium level is the predominant intracellular cation. It is fundamental for correct neuromuscular activity
Sodium (cNa+): The sodium ion is the most abundant cation in plasma. It is the foremost agent involved in maintenance of osmolality and body fluid volumes.
Calcium (cCa 2+): The calcium ion is the most abundant mineral element in the human body and is involved in numerous enzymatic processes, blood coagulation, cell growth, and membrane transport mechanisms as well as plays an important role in nervous impulse conduction, neuromuscular transmission, and muscular contraction and relaxation.
Chloride (cCl): The chloride ion is the main extracellular anion and plays an important role in maintaining electrical neutrality.
Hematocrit (Hct): The hematocrit measurement is the ratio of the volume of red blood cells in whole blood in comparison to the total volume.
Glucose (cGlu): The glucose measurements are used to screen for, diagnose and monitor glycemic levels in potential pre-diabetic, diabetic, hypoglycemic patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051804: ABL80 Flex Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051804
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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