510(k) · Cleared
Recalled · Class II · 2012ABL835 Flex Analyzer with Pleural PH
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 Mar 24, 2011 as substantially equivalent to K050423 (Roche Diagnostics, 2005) after a 38-day review. Its family tree reaches back 2 generations to 1987. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 24, 2011
- Review
- 38 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. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK872888 Ciba Corning 288 PH/Blood Gas SystemCiba Corning Diagnostics Corp. · 1987
- 1 generation backK050423 Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics · 2005
- This deviceK110416 ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011
- Descendant · cites it directly · 4 of its ownK122539 Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013
- Descendant · 2 generations on · 3 of its ownK192240 RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK223857 i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · Recalled
- Descendant · 4 generations on · 0 of its ownK244014 i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · Recalled
- Descendant · 3 generations on · 0 of its ownK230285 i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K122539Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013 · cites it directly4descendants
- K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020 · 2 generations on3descendants
- K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 3 generations on1descendant
- K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 4 generations on0descendants
- K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 3 generations on0descendants
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) | K110416 | ABL835 Flex Analyzer with Pleural PH | Radiometer Medical Aps | 2011 | — |
| +1 | K122539 | Measurement of PH in Pleural Fluid on Blood Gas System | Siemens Healthcare Diagnostics | 2013 | — |
| +2 | K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020 | 4 |
| +3 | K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | 1 |
| +4 | K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025 | 1 |
| +3 | K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K050423 | Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Summary page 2…ice ABL835 FLEX analyzer with pleural Roche analyzer PH K050423 Indications for use New indication for measuring of pH in Same pleural fluids Blood Gas Mea… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122539 | Measurement of PH in Pleural Fluid on Blood Gas System | 2013 | 4 |
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 24 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.
- Of its descendants, K122539 (Siemens Healthcare Diagnostics, 2013) has gone furthest, with 4 descendants of its own.
- 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. 2011, 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 ABL835 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 effuisions 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/K110416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110416: ABL835 Flex Analyzer with Pleural PH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110416
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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