510(k) · Cleared
Clearedi-STAT CHEM8+ 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. · CGA Glucose Oxidase, Glucose
Cleared on Aug 13, 2021 as substantially equivalent to K183678 (Abbott Point of Care, Inc., 2020) and 4 other predicates after a 135-day review. Its family tree reaches back 4 generations to 1988. 3 later devices descend from it.
- Decided
- Aug 13, 2021
- Review
- 135 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K883181 (1988). 15 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- 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 backK183678 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- This deviceK210958 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK223755 i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252488 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
- Descendant · cites it directly · 0 of its ownK223710 i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · cites it directly1descendant
- K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026 · 2 generations on0descendants
- K223710i-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 | 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 | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| 0 (this device) | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021 | — |
| +1 | K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
| +2 | K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026 | — |
| +1 | K223710 | 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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2026 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K183678 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemSummary page 5…Measuring 3. Predicate Device Proprietary Name i-STAT CHEM8+ cartridge with the i-STAT 1 System 510(k) Numbers K183678 K183688 K191298 K191360… | 2020 |
| * | K183688 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemSummary page 5…Predicate Device Proprietary Name i-STAT CHEM8+ cartridge with the i-STAT 1 System 510(k) Numbers K183678 K183688 K191298 K191360 K183680… | 2020 |
| * | K191298 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemSummary page 5…Name i-STAT CHEM8+ cartridge with the i-STAT 1 System 510(k) Numbers K183678 K183688 K191298 K191360 K183680 Product Device Cla… | 2020 |
| * | K191360 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemSummary page 5…h the i-STAT 1 System 510(k) Numbers K183678 K183688 K191298 K191360 K183680 Product Device Classification Regulation 5… | 2020 |
| * | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 SystemSummary page 5…bers K183678 K183688 K191298 K191360 K183680 Product Device Classification Regulation 510(k) Number code… | 2020 |
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)
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 33 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- 7 of the 15 ancestors have a recall of any class.
- Of its descendants, K223755 (Abbott Point of Care, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous 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…
Read the full statement (263 words)
The i-STAT CHEM8+ cartridge with the i-STAT 1 System is intended for use in the in vitro quantification of sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit, and total carbon dioxide in arterial or venous 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.
Chloride measurements are primarily used in the diagnosis, monitoring, and treatment of electrolyte and metabolic disorders including, but not limited to, cystic fibrosis, diabetic acidosis, and hydration disorders.
Ionized calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
Glucose measurements are used in the diagnosis, monitoring, and treatment of carbohydrate metabolism disorders including, but not limited to, diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Blood urea nitrogen measurements are used for the diagnosis, monitoring, and treatment of certain renal and metabolic diseases.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status that can be associated with conditions including anemia and erythrocytosis. The i-STAT Hematocrit test has not been evaluated in neonates.
Carbon dioxide measurements are used in the diagnosis, monitoring, and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210958 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210958: i-STAT CHEM8+ cartridge with the i-STAT 1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210958
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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