# K912387: I-Stat Model 100 Port Clin Analyzer & Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corp.
- Decided: Jul 1, 1991 after 61 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: 9 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Feb 5, 2010 · Not classified · Z-1798-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
- Feb 5, 2010 · Not classified · Z-1797-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
- Feb 5, 2010 · Not classified · Z-1796-2010: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
- Feb 23, 2009 · Not classified · Z-1540-2009: Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.
- Oct 18, 2007 · Not classified · Z-0371-2008: 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-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/K912387
Methodology: https://510kreport.com/methodology