510(k) Report

FDA applicant

I-Stat Corp.

East Windsor, NJ21 decisions1989–200669 recalls

FDA records 21 decisions for I-Stat Corp. (East Windsor, NJ) from 1989 to 2006: 21 510(k) clearances. Most are in product codes JGS (Electrode, Ion Specific, Sodium) and CHL (Electrode Measurement, Blood-Gases (Pco2, Po2)…). Its devices cite 1 predicate, 1 of them its own earlier devices. 69 recalls are linked to its devices.

FDA’s records also spell it “I-Stat Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided I-Stat Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for I-Stat Corp. since 2007.

Recalls per year

2in 2026

2007: 62008: 32009: 82010: 222011: 92012: 62013: 12014: 12015: 12018: 12019: 12020: 22025: 22026 (partial year): 2
2007high 22 (2010) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — I-Stat Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JGSElectrode, Ion Specific, Sodium4decisions
  • CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph3decisions
  • KHPAcid, Lactic, Enzymatic Method2decisions
  • JBPActivated Whole Blood Clotting Time2decisions
  • CGLElectrode, Ion Based, Enzymatic, Creatinine1decision
  • JJYMulti-Analyte Controls, All Kinds (Assayed)1decision

Also: MMI (1), CGA (1), MYT (1), JJX (1), NBC (1), JFP (1).

Who builds on its devices?

Later devices cite its devices 18 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K001387I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 20006cite it
  • K940918I-Stat 200 Portable Clinical AnalyzerI-Stat Corp. · 19945cite it
  • K982071I-Stat Lactate TestI-Stat Corp. · 19982cite it
  • K934641I-Stat Control Levels 1,2,3I-Stat Corp. · 19932cite it
  • K973292I-Stat SystemI-Stat Corp. · 19971cites it
  • K011478I-Stat SystemI-Stat Corp. · 20011cites it

What has FDA decided for it lately?

  • K053597I-Stat B-Type Natriuretic Peptide (BNP)I-Stat Corporation · 20062 recalls
  • K053110Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+…I-Stat Corporation · 20063 recalls
  • K051433I-Stat Creatine Kinase MB (CK-MB)I-Stat Corporation · 20054 recalls
  • K031873I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control SetI-Stat Corporation · 20032 recalls
  • K023582I-Stat Kaolin Act TestI-Stat Corporation · 20032 recalls
  • K031739I-Stat Cardiac Troponin (Ctni) TestI-Stat Corporation · 20035 recalls
  • K020355I-Stat Prothrombin Time TestI-Stat Corporation · 20025 recalls
  • K012478Modification to: I-Stat Portable Clinical AnalyzerI-Stat Corp. · 2001

All 14 as I-Stat Corp. →All 7 as I-Stat Corporation →

What has been recalled?

69 recalls linked to its devices; the latest:

  • K940918i-STAT EG6+ cartridge; List Number: 03P77-25;Apr 1, 2026Class II
  • K940918i-STAT EG7+ cartridge; List Number: 03P76-25;Apr 1, 2026Class II
  • K244014i-STAT CG4+ cartridge (white). List Number: 03P85-25.Aug 21, 2025Class II
  • K053110Abbott Point of Care Test Crea I-Stat (25/BX) Abbtpt Cartridge.Apr 24, 2025Class II
  • K940918Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium…Dec 22, 2020Class II
  • K940918Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium…Dec 22, 2020Class II