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. · JPI Device, Hematocrit Measuring
Cleared on Feb 28, 2020 as substantially equivalent to K163342 (Abbott Laboratories, 2017) after a 427-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- Feb 28, 2020
- Review
- 427 days
- Class
- Class II
- Product code
- JPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001387 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
- 2 generations backK103195 I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc. · 2011
- 1 generation backK163342 i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories · 2017
- This deviceK183680 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK210958 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK223755 i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK252488 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
- Descendant · 2 generations on · 0 of its ownK223710 i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021 · cites it directly3descendants
- K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 2 generations on1descendant
- K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026 · 3 generations on0descendants
- K223710i-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 | K001387 | I-Stat Portable Clinical Analyzer, Model 300 | I-Stat Corp. | 2000 | 13 |
| −2 | K103195 | I-Stat 1 Wireless Analyzer | Abbott Point of Care, Inc. | 2011 | — |
| −1 | K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories | 2017 | — |
| 0 (this device) | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +1 | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021 | — |
| +2 | K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
| +3 | K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026 | — |
| +2 | K223710 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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 JPI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K163342 | i-STAT Hematocrit test with i-STAT Alinity SystemSummary page 4…cate Device Proprietary Name i-STAT Hematocrit test on the i-STAT EC4+ cartridge with the i-STAT Alinity System 510(k) Number k163342 Product Device Classification Regulation code name Number Class… | 2017 |
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 |
|---|---|---|---|
| K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2021 | 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 20 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K210958 (Abbott Point of Care, Inc., 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All JPI devicesJPI Device, Hematocrit Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JPI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JPI
Too few JPI 510(k)s in any year since 2007 to give a median.
Recalls per year · JPI
8in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPI
34in 2025
MAUDE reports naming product code JPI, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 8 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 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 hematocrit in arterial or venous whole blood in point of care or clinical laboratory settings.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183680 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183680: 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 5, 2026. https://510kreport.com/device/K183680
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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