510(k) · Cleared
ClearedMeasurement of PH in Pleural Fluid on Blood Gas System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Apr 19, 2013 as substantially equivalent to K110416 (Radiometer Medical Aps, 2011) after a 241-day review. Its family tree reaches back 3 generations to 1987. 4 later devices descend from it.
- Decided
- Apr 19, 2013
- Review
- 241 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K872888 (1987). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK872888 Ciba Corning 288 PH/Blood Gas SystemCiba Corning Diagnostics Corp. · 1987
- 2 generations backK050423 Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics · 2005
- 1 generation backK110416 ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011 · Recalled
- This deviceK122539 Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013
- Descendant · cites it directly · 3 of its ownK192240 RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK223857 i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK244014 i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · Recalled
- Descendant · 2 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 4 of 4 · See all- K192240RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020 · cites it directly3descendants
- K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 2 generations on1descendant
- K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 3 generations on0descendants
- K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872888 | Ciba Corning 288 PH/Blood Gas System | Ciba Corning Diagnostics Corp. | 1987 | — |
| −2 | K050423 | Omni Modular, Omni C and Omni S Analyzer (PH Electrode) | Roche Diagnostics | 2005 | — |
| −1 | K110416 | ABL835 Flex Analyzer with Pleural PH | Radiometer Medical Aps | 2011 | 2 |
| 0 (this device) | K122539 | Measurement of PH in Pleural Fluid on Blood Gas System | Siemens Healthcare Diagnostics | 2013 | — |
| +1 | K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020 | 4 |
| +2 | K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | 1 |
| +3 | K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025 | 1 |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K110416 | ABL835 Flex Analyzer with Pleural PHSummary page 1…Predicate Device Device Name ABL835 FLEX Analyzer With Pleural pH Common Name Pleural Fluid pH 51()Number K1 10416 Manufacturer Radiometer Medical ApS 4.0 Device Description The RP400/405/500 system is a point-of-c… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192240 | RAPIDPoint 500e Blood Gas System | 2020 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K192240 (Siemens Healthcare Diagnostics, Inc., 2020) has gone furthest, with 3 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. 2013, 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?
RAPIDPoint® 400/405/500 systems are intended for in vitro testing of pleural fluid samples for the pH parameter. Test systems are intended for use in point of care or laboratory settings.
The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
The following critical value applies to pleural fluid pH: pH > 7.3 is measured in uncomplicated parapneumonic effusions. All pleural fluids with a pH measurement < 7.3 are referred to as complicated parapneumonic effusions, and are exudative in nature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122539: Measurement of PH in Pleural Fluid on Blood Gas System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122539
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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