510(k) · Cleared
Recalled · Class II · 2020Abl 80 CO-OX System
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 Jul 31, 2008 as substantially equivalent to K051804 (Sendx Medical, Inc., 2005) and 1 other predicate after a 170-day review. Its family tree reaches back 7 generations to 1986. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Jul 31, 2008
- Review
- 170 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 7 generations to K861087 (1986). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 6 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 5 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 4 generations backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- 3 generations backK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- 2 generations backK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- 1 generation backK051804 ABL80 Flex AnalyzerSendx Medical, Inc. · 2005 · Recalled
- This deviceK080370 Abl 80 CO-OX SystemSendx Medical, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK151856 ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc. · 2015 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −6 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −5 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −4 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| −3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| −2 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| −1 | K051804 | ABL80 Flex Analyzer | Sendx Medical, Inc. | 2005 | 4 |
| 0 (this device) | K080370 | Abl 80 CO-OX System | Sendx Medical, Inc. | 2008 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K051804 | ABL80 Flex AnalyzerSummary page 2…y equivalent in features and characteristics to the predicate ABL80 FLEX and the ABL 700. 510(k3 Number Device Manufacturer K051804 ABL80 FLEX SenDx Medical, Inc. K980130 ABL 700 Series… | 2005 |
| * | K980130 | ABL700 Series Blood Gas , CO-Oximetry, Electrolyte & Metabolite SystemSummary page 2…ABL 700. 510(k3 Number Device Manufacturer K051804 ABL80 FLEX SenDx Medical, Inc. K980130 ABL 700 Series Radiometer Medical ApS With each of the listed devices and the ABL80 FLEX C… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | 2015 | 0 |
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-2468-2020 | 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 6, 2010 | Class II | Z-0195-2013 | Software design | The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters. |
| Feb 20, 2009 | Not classified | Z-0150-2010 | Other | Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 12 of the 19 ancestors have a recall of any class.
- Of its descendants, K151856 (Sendx Medical, Inc., 2015) has gone furthest, with 0 descendants 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. 2008, 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 ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. These tests are only performed under a physician's order: pH, p0 2,and pCO 2 , : pH, pCO2 and PO2 measurements are used…
Read the full statement (316 words)
The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
These tests are only performed under a physician's order:
pH, p0 2,and pCO 2 , : pH, pCO2 and PO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium (cK+): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Sodium (cNa+): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Calcium (cCa 2*): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Chloride (cCI-): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
Glucose (cGlu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The following six parameters will be introduced with the ABL80 FLEX CO-OX:
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sO 2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
FO 2 Hb: oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: methemoglobin as a fraction of total hemoglobin.
FHHb: reduced hemoglobin as a fraction of total hemoglobin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080370: Abl 80 CO-OX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080370
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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