Ionetics, Inc.: FDA clearances and approvals
Ionetics, Inc. has 7 FDA 510(k) clearances (first 1981, latest 1993), across 4 product codes in 2 review panels. Median 510(k) review time: 75 days.
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 |
|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | 2 | 2 |
| JFP | Electrode, Ion Specific, Calcium | 2 | 2 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 2 |
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Microbiology (1)
Most recent Ionetics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932179 | MODEL 400/450 ELECTROLYTE ANALYZER | JGS | 1993-11-17 | 196 |
| K895397 | CALCIUM AND PH ELECTROLYTE ANALYZER | JFP | 1989-12-12 | 102 |
| K890792 | POTASSIUM AND SODIUM ELECTROLYTE ANALYZER | CEM | 1989-05-03 | 75 |
| K863907 | MODIFIED SODIUM ELECTRODE | JGS | 1986-12-10 | 64 |
| K851808 | ELECTROLYTE ANALYZER | CEM | 1985-06-25 | 71 |
| K830130 | MINIATURE ION SELECTIVE ELECTRODES | JSG | 1983-03-07 | 55 |
| K802856 | MINIATURE ION SELECTIVE ELECTRODES | JFP | 1981-01-28 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Ionetics, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances does Ionetics, Inc. have?
Ionetics, Inc. has 7 FDA 510(k) clearances (first 1981, latest 1993), across 4 product codes in 2 review panels.
How long does FDA take to clear Ionetics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ionetics, Inc.'s cleared 510(k)s is 75 days.
What devices does Ionetics, Inc. make?
Its most frequent FDA product codes are CEM (Electrode, Ion Specific, Potassium, 2); JFP (Electrode, Ion Specific, Calcium, 2); JGS (Electrode, Ion Specific, Sodium, 2).
Has Ionetics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ionetics, Inc. Related entities may recall under other names.
Next steps
- See all 7 Ionetics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CEM, Ionetics, 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.