510(k) · Cleared
Recalled · Class II · 2024RAPIDPoint 500e Blood Gas System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Mar 27, 2020 as substantially equivalent to K122539 (Siemens Healthcare Diagnostics, 2013) after a 221-day review. Its family tree reaches back 4 generations to 1987. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 27, 2020
- Review
- 221 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 4 generations to K872888 (1987). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK872888 Ciba Corning 288 PH/Blood Gas SystemCiba Corning Diagnostics Corp. · 1987
- 3 generations backK050423 Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics · 2005
- 2 generations backK110416 ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011 · Recalled
- 1 generation backK122539 Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013
- This deviceK192240 RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK223857 i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK244014 i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · Recalled
- Descendant · cites it directly · 0 of its ownK230285 i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · cites it directly1descendant
- K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2025 · 2 generations on0descendants
- K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K872888 | Ciba Corning 288 PH/Blood Gas System | Ciba Corning Diagnostics Corp. | 1987 | — |
| −3 | K050423 | Omni Modular, Omni C and Omni S Analyzer (PH Electrode) | Roche Diagnostics | 2005 | — |
| −2 | K110416 | ABL835 Flex Analyzer with Pleural PH | Radiometer Medical Aps | 2011 | 2 |
| −1 | K122539 | Measurement of PH in Pleural Fluid on Blood Gas System | Siemens Healthcare Diagnostics | 2013 | — |
| 0 (this device) | K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020 | — |
| +1 | K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | 1 |
| +2 | K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025 | 1 |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K122539 | Measurement of PH in Pleural Fluid on Blood Gas SystemSummary page 10…Blood Gasses (pCO2) (pO2) and Blood pH Test System FDA Product Codes CHL, JGS, CEM, JFP, CGZ, CGA, GKR, MQM, KHP 510(k) Number K122539 Manufacturer Siemens Healthcare Diagnostics Inc. The RAPIDPoint 500e Blood Gas System is substanti… | 2013 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2024 | Class II | Z-2214-2024 | Software Design Change | Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in… |
| Sep 26, 2023 | Class II | Z-0422-2024 | Under Investigation by firm | There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The erroneous sodium levels… |
| Jun 1, 2022 | Class II | Z-1372-2022 | Under Investigation by firm | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support. |
| May 27, 2020 | Class II | Z-2432-2020 | Software design | The scanner is not confirming the integrity of read barcode data using the check-digit when reading Code 39 barcodes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K223857 (Abbott Point of Care, Inc., 2023) 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. 2020, 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 RAPIDPoint® 500e Blood Gas System is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters: • Partial pressure of carbon dioxide • Partial pressure of oxygen • pH • Sodium • Potassium • Ionized Calcium • Chloride • Glucose • Lactate • Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb • Neonatal Bilirubin The RAPIDPoint 500e Blood Gas System is also intended for in vitro…
Read the full statement (517 words)
The RAPIDPoint® 500e Blood Gas System is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:
• Partial pressure of carbon dioxide
• Partial pressure of oxygen
• pH
• Sodium
• Potassium
• Ionized Calcium
• Chloride
• Glucose
• Lactate
• Total Hemoglobin and fractions: FO2Hb, FCOHb, FMetHb, FHHb
• Neonatal Bilirubin
The RAPIDPoint 500e Blood Gas System is also intended for in vitro testing of pleural fluid samples for the pH parameter. 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. This test system is intended for use in point of care or laboratory settings.
The following list includes the Indications for Use information for each analyte measured on the RAPIDPoint 500e Blood Gas System:
Lactate: A lactic acid test system is a device intended to measure lactic acid in whole blood. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
Neonate Bilirubin: A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
pCO2, p02, pH: Measurements of blood gases (pCO2, p02) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Sodium: Sodium measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium: Potassium measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride: Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Ionized calcium: Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Glucose: 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.
Total hemoglobin: Total hemoglobin measurements are used to determine the hemoglobin content of human blood.
Oxyhemoglobin: Oxyhemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
Carboxyhemoglobin: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin (the compound formed when hemoglobin is exposed to carbon monoxide) content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192240: RAPIDPoint 500e 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/K192240
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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