# K001154: I-Stat Model 200 Portable Clinical Analyzer

- Pathway: 510(k) (Special)
- Applicant: I-Stat Corp.
- Decided: Apr 18, 2000 after 8 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Oct 18, 2007 · Not classified · Z-0370-2008: Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
- Oct 18, 2007 · Not classified · Z-0372-2008: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
- Oct 18, 2007 · Not classified · Z-0374-2008: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.
- Oct 18, 2007 · Not classified · Z-0375-2008: Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

Source page: https://510kreport.com/device/K001154
Methodology: https://510kreport.com/methodology