Abbott Point of Care, Inc.: FDA clearances and approvals
Abbott Point of Care, Inc. has 22 FDA 510(k) clearances (first 2011, latest 2026), across 10 product codes in 3 review panels. Median 510(k) review time: 266 days. Since 2017 its median was 266 days, against 240 days for all cleared 510(k)s in the same product codes. openFDA lists 77 product recalls by a recalling firm named Abbott Point of Care, Inc. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 569 |
| 2016 | 1 | 231 |
| 2017 | 1 | 140 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 6 | 338 |
| 2021 | 1 | 135 |
| 2022 | 0 | — |
| 2023 | 6 | 266 |
| 2024 | 1 | 89 |
| 2025 | 2 | 198 |
| 2026 | 2 | 175 |
Review time against the same product codes
Since 2017, Abbott Point of Care, Inc.'s cleared 510(k)s took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 240 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 6 | 6 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 4 | 4 |
| JGS | Electrode, Ion Specific, Sodium | 3 | 3 |
| JFP | Electrode, Ion Specific, Calcium | 2 | 2 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 2 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 1 | 1 |
| DHA | System, Test, Human Chorionic Gonadotropin | 1 | 1 |
| JFL | Ph Rate Measurement, Carbon-Dioxide | 1 | 1 |
| JPI | Device, Hematocrit Measuring | 1 | 1 |
| QAT | Brain Trauma Assessment Test | 1 | 1 |
Review panels
- Clinical Chemistry (20)
- Hematology (1)
- Immunology (1)
Most recent Abbott Point of Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261039 | i-STAT Crea cartridge with the i-STAT 1 System | CGL | 2026-06-26 | 88 |
| K253051 | i-STAT hs-TnI cartridge with the i-STAT Alinity System | MMI | 2026-06-11 | 262 |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | CHL | 2025-05-02 | 127 |
| K240984 | i-STAT hs-TnI cartridge with the i-STAT 1 System | MMI | 2025-01-03 | 268 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | QAT | 2024-03-27 | 89 |
| K230300 | i-STAT CG8+ cartridge with the i-STAT 1 System | JFP | 2023-10-27 | 266 |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | CHL | 2023-10-27 | 267 |
| K230275 | i-STAT CG8+ cartridge with the i-STAT 1 System | JGS | 2023-10-27 | 268 |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | CHL | 2023-09-15 | 266 |
| K223755 | i-STAT G cartridge with the i-STAT 1 System | CGA | 2023-09-11 | 270 |
12 earlier clearances. See the full list in Caduvo.
Recalls
77 product recalls in 40 recall events; 7 initiated in the last five years. Most recent: 2026-04-01.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Abbott Point of Care, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06295835: Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in Blood (Completed, started 2024-05-31)
- NCT07382076: Clinical Evaluation of the i-STAT ACTpro Cartridge in an Adult Population (Active not recruiting, started 2023-12-15)
Frequently asked questions
How many FDA 510(k) clearances does Abbott Point of Care, Inc. have?
Abbott Point of Care, Inc. has 22 FDA 510(k) clearances (first 2011, latest 2026), across 10 product codes in 3 review panels.
How long does FDA take to clear Abbott Point of Care, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Abbott Point of Care, Inc.'s cleared 510(k)s is 266 days. Since 2017: 266 days, versus 240 days for all cleared 510(k)s in the same product codes.
What devices does Abbott Point of Care, Inc. make?
Its most frequent FDA product codes are CGA (Glucose Oxidase, Glucose, 6); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 4); JGS (Electrode, Ion Specific, Sodium, 3).
Has Abbott Point of Care, Inc. had device recalls?
openFDA lists 77 product recalls in 40 recall events by a recalling firm whose name matches Abbott Point of Care, Inc; the most recent began 2026-04-01. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 22 Abbott Point of Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Abbott Point of Care, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.