I-Stat Corp.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under 2 spellings of the applicant name “I-Stat Corp.” (first 1989, latest 2006), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 79 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | 4 | 4 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 3 | 3 |
| JBP | Activated Whole Blood Clotting Time | 2 | 2 |
| KHP | Acid, Lactic, Enzymatic Method | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
| JFP | Electrode, Ion Specific, Calcium | 1 | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
Plus 4 more product codes.
Review panels
- Clinical Chemistry (18)
- Hematology (3)
Most recent I-Stat Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053597 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) | NBC | 2006-07-21 | 210 |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge | JGS | 2006-01-13 | 70 |
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) | MYT | 2005-12-15 | 197 |
| K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET | JJX | 2003-10-07 | 112 |
| K023582 | I-STAT KAOLIN ACT TEST | JBP | 2003-09-08 | 319 |
| K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST | MMI | 2003-09-02 | 90 |
| K020355 | I-STAT PROTHROMBIN TIME TEST | GJS | 2002-05-14 | 99 |
| K012478 | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER | CHL | 2001-08-20 | 18 |
| K011478 | I-STAT SYSTEM | KHP | 2001-07-02 | 49 |
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | CGA | 2000-10-05 | 156 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named I-Stat Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- I-Stat Corp. (14)
- I-Stat Corporation (7)
Frequently asked questions
How many FDA 510(k) clearances are listed under I-Stat Corp.?
FDA lists 21 510(k) clearances under 2 spellings of the applicant name “I-Stat Corp.” (first 1989, latest 2006), across 14 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by I-Stat Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name I-Stat Corp. is 79 days.
Which FDA product codes appear under I-Stat Corp.?
The most frequent FDA product codes under this applicant name are JGS (Electrode, Ion Specific, Sodium, 4); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 3); JBP (Activated Whole Blood Clotting Time, 2).
Next steps
- See all 21 I-Stat Corp. clearances with predicates and recalls
- Run predicate analysis for product code JGS, I-Stat Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.