510(k) · Cleared
Clearedi-STAT Hematocrit test with i-STAT Alinity System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JPI Device, Hematocrit Measuring
Cleared on Aug 22, 2017 as substantially equivalent to K103195 (Abbott Point of Care, Inc., 2011) after a 266-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- Aug 22, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- JPI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001387 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000 · Recalled
- 1 generation backK103195 I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc. · 2011
- This deviceK163342 i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories · 2017
- Descendant · cites it directly · 4 of its ownK183680 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK210958 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK223755 i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK252488 ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
- Descendant · 3 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 5 of 5 · See all- K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · cites it directly4descendants
- K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2021 · 2 generations on3descendants
- K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 3 generations on1descendant
- K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026 · 4 generations on0descendants
- K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001387 | I-Stat Portable Clinical Analyzer, Model 300 | I-Stat Corp. | 2000 | 13 |
| −1 | K103195 | I-Stat 1 Wireless Analyzer | Abbott Point of Care, Inc. | 2011 | — |
| 0 (this device) | K163342 | i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories | 2017 | — |
| +1 | K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020 | — |
| +2 | K210958 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2021 | — |
| +3 | K223755 | i-STAT G cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023 | — |
| +4 | K252488 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2026 | — |
| +3 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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.
Top candidate predicates for a new JPI device
- #1 K183680 i-STAT CHEM8+ cartridge with the i-STAT 1 Systemscore 2.5 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K103195 | I-Stat 1 Wireless AnalyzerSummary page 4…Sodium 3. Predicate Device Proprietary Name i-STAT Hematocrit test with i-STAT 1 Wireless Analyzer 510(k) Number K103195 Product Device Classification Regulation Class Panel code name Num… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183680 | i-STAT CHEM8+ cartridge with the i-STAT 1 System | 2020 | 4 |
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 17 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K183680 (Abbott Point of Care, Inc., 2020) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K103195.
How does its category compare?
All JPI devicesJPI Device, Hematocrit Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood. The i-STAT Hematocrit test is intended for use in the in vitro quantification of packed red blood cell volume fraction in arterial or venous heparinized whole blood, or in arterial or venous non-anticoagulated…
Read the full statement (137 words)
The i-STAT Alinity instrument with i-STAT tests is intended for use in point of care or clinical laboratory settings. The i-STAT Alinity system is intended for the quantitative measurement of various analytes in arterial and venous whole blood.
The i-STAT Hematocrit test is intended for use in the in vitro quantification of packed red blood cell volume fraction in arterial or venous heparinized whole blood, or in arterial or venous non-anticoagulated whole blood.
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 with the i-STAT Alinity System has not been evaluated in neonates.
The i-STAT Hematocrit test with the i-STAT Alinity System is not for use with capillary samples.
For in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163342: i-STAT Hematocrit test with i-STAT Alinity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163342
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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