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. · JGS Electrode, Ion Specific, Sodium
Cleared on Oct 27, 2023 as substantially equivalent to K183688 (Abbott Point of Care, Inc., 2020) after a 268-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Oct 27, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- JGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K883181 (1988). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK883181 Synchron CX4/CX5 Clinical Chemistry Analyzer ReageBeckman Instruments, Inc. · 1988 · Recalled
- 3 generations backK965240 Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin…Beckman Instruments, Inc. · 1997 · Recalled
- 2 generations backK042291 Unicel DXC 600 and 800 Synchron SystemsBeckman Coulter, Inc. · 2004 · Recalled
- 1 generation backK183688 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- This deviceK230275 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 |
|---|---|---|---|---|---|
| −4 | K883181 | Synchron CX4/CX5 Clinical Chemistry Analyzer Reage | Beckman Instruments, Inc. | 1988 | 2 |
| −3 | K965240 | Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent… | Beckman Instruments, Inc. | 1997 | 12 |
| −2 | K042291 | Unicel DXC 600 and 800 Synchron Systems | Beckman Coulter, Inc. | 2004 | 34 |
| −1 | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| 0 (this device) | K230275 | 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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 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 JGS? 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 JGS device
- #1 K252475 ABL90 FLEX PLUS Systemscore 12.2 · 4 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 |
|---|---|---|---|
| * | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemSummary page 4…Specific, Potassium III. PREDICATE DEVICE Proprietary Name i-STAT CHEM8+ cartridge with the i-STAT 1 System 510(k) Number K183688 510(k) Summary Page 1 of 11 Product… | 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 35 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 5 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K183688.
How does its category compare?
All JGS devicesJGS Electrode, Ion Specific, Sodium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · JGS
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JGS
347in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JGS
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGS
64in 2025
MAUDE reports naming product code JGS, 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 | 0 | — | 7 | 33 |
| 2008 | 2 | — | 1 | 3 |
| 2009 | 2 | — | 0 | 57 |
| 2010 | 1 | — | 1 | 361 |
| 2011 | 3 | 191 | 1 | 912 |
| 2012 | 1 | — | 2 | 412 |
| 2013 | 2 | — | 5 | 510 |
| 2014 | 1 | — | 0 | 251 |
| 2015 | 1 | — | 1 | 158 |
| 2016 | 4 | 198 | 0 | 84 |
| 2017 | 1 | — | 0 | 292 |
| 2018 | 3 | 180 | 0 | 158 |
| 2019 | 3 | 58 | 5 | 105 |
| 2020 | 2 | — | 1 | 89 |
| 2021 | 0 | — | 1 | 91 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 3 | 347 | 4 | 98 |
| 2024 | 0 | — | 0 | 96 |
| 2025 | 0 | — | 0 | 64 |
| 2026 | 1 | — | 0 | — |
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 sodium and potassium in arterial or venous whole blood in point of care or clinical laboratory settings.
The i-STAT CG8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium in capillary whole blood in point of care or clinical laboratory settings.
Sodium measurements are used for monitoring electrolyte imbalances.
Potassium measurements are used in the diagnosis and monitoring of diseases and clinical conditions that manifest high and low potassium levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230275: 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/K230275
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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