# K001387: I-Stat Portable Clinical Analyzer, Model 300

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corp.
- Decided: Oct 5, 2000 after 156 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 6 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K103195: I-Stat 1 Wireless Analyzer (2011), 8 descendants of its own
- K061597: Epoc Blood Analysis System (2006), 7 descendants of its own
- K191360: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 5 descendants of its own
- K163342: i-STAT Hematocrit test with i-STAT Alinity System (2017), 5 descendants of its own
- K183680: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own

## Recalls of this device
- Sep 8, 2011 · Class II · Z-1973-2012: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
- Sep 8, 2011 · Class II · Z-1975-2012: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
- Sep 8, 2011 · Class II · Z-1974-2012: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
- Sep 8, 2011 · Class II · Z-1976-2012: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
- Sep 8, 2011 · Class II · Z-1978-2012: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
- Sep 8, 2011 · Class II · Z-1977-2012: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
- Sep 20, 2010 · Not classified · Z-0598-2011: i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
- Sep 20, 2010 · Not classified · Z-0597-2011: i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
- Aug 20, 2010 · Not classified · Z-2462-2010: Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
- Nov 6, 2009 · Not classified · Z-1133-2010: Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.
- Sep 29, 2009 · Not classified · Z-0865-2010: Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the inc
- Sep 9, 2009 · Not classified · Z-0812-2010: The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
- Apr 22, 2009 · Not classified · Z-2328-2009: It appears that the rechargeable battery pack is overheating with or without the presence of smoke.

Source page: https://510kreport.com/device/K001387
Methodology: https://510kreport.com/methodology