510(k) · Cleared
Recalled · Class II · 2012ABL837 Flex Analyzer
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 Dec 10, 2010 as substantially equivalent to K050423 (Roche Diagnostics, 2005) after a 267-day review. Its family tree reaches back 2 generations to 1987. It has been recalled 2 times.
- Decided
- Dec 10, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K872888 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872888 | Ciba Corning 288 PH/Blood Gas System | Ciba Corning Diagnostics Corp. | 1987 | — |
| −1 | K050423 | Omni Modular, Omni C and Omni S Analyzer (PH Electrode) | Roche Diagnostics | 2005 | — |
| 0 (this device) | K100777 | ABL837 Flex Analyzer | Radiometer Medical Aps | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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? (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 |
|---|---|---|---|
| * | K050423 | Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Summary page 2…e ABL837 FLEX analyzer with pleural Roche analyzer pH K050423 Indications for use New indication for measuring of pH in Same pleural fluids Blood Gas Me… | 2005 |
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 5, 2012 | Class II | Z-2163-2012 | Software design | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are… |
| Jul 5, 2012 | Class II | Z-2162-2012 | Software design | A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 17.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K050423.
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. 2010, 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 ABL837 FLEX analyzer is intended for:
in vitro testing of pleural fluid samples for the pH parameter
The pH measurement of pleural fluid can be a clinically usefuil 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/K100777 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100777: ABL837 Flex Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100777
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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