510(k) · Cleared
Clearedi-STAT CG8+ cartridge with the i-STAT 1 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Point of Care, Inc. · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on Oct 27, 2023 as substantially equivalent to K192240 (Siemens Healthcare Diagnostics, Inc., 2020) after a 267-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Oct 27, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- CHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K872888 (1987). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK872888 Ciba Corning 288 PH/Blood Gas SystemCiba Corning Diagnostics Corp. · 1987
- 4 generations backK050423 Omni Modular, Omni C and Omni S Analyzer (PH Electrode)Roche Diagnostics · 2005
- 3 generations backK110416 ABL835 Flex Analyzer with Pleural PHRadiometer Medical Aps · 2011 · Recalled
- 2 generations backK122539 Measurement of PH in Pleural Fluid on Blood Gas SystemSiemens Healthcare Diagnostics · 2013
- 1 generation backK192240 RAPIDPoint 500e Blood Gas SystemSiemens Healthcare Diagnostics, Inc. · 2020 · Recalled
- This deviceK230285 i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K872888 | Ciba Corning 288 PH/Blood Gas System | Ciba Corning Diagnostics Corp. | 1987 | — |
| −4 | K050423 | Omni Modular, Omni C and Omni S Analyzer (PH Electrode) | Roche Diagnostics | 2005 | — |
| −3 | K110416 | ABL835 Flex Analyzer with Pleural PH | Radiometer Medical Aps | 2011 | 2 |
| −2 | 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 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K192240 | RAPIDPoint 500e Blood Gas SystemSummary page 5…Page 1 of 13 III. PREDICATE DEVICE Proprietary Name RAPIDPoint 500e Blood Gas System 510(k) Number K192240 Product Device Classification Regulation Class… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 36 years and passes through 6 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K192240.
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. 2023, 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 i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of pH, partial pressure of oxygen (P02), and partial pressure of carbon dioxide (PCO2) in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.
pH, P02, and PCO2 measurements are used in the diagnosis, monitoring, and treatment of respiratory, metabolic and acid-base disturbances.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230285: i-STAT CG8+ cartridge with the i-STAT 1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230285
Report an extraction error
Are you the manufacturer?
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