Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ionetics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
196 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K932179 | MODEL 400/450 ELECTROLYTE ANALYZER | Ionetics, Inc. | 1993-11-17 | 196 | 0 |
| K895397 | CALCIUM AND PH ELECTROLYTE ANALYZER | Ionetics, Inc. | 1989-12-12 | 102 | 0 |
| K890792 | POTASSIUM AND SODIUM ELECTROLYTE ANALYZER | Ionetics, Inc. | 1989-05-03 | 75 | 0 |
| K863907 | MODIFIED SODIUM ELECTRODE | Ionetics, Inc. | 1986-12-10 | 64 | 0 |
| K851808 | ELECTROLYTE ANALYZER | Ionetics, Inc. | 1985-06-25 | 71 | 0 |
| K830130 | MINIATURE ION SELECTIVE ELECTRODES | Ionetics, Inc. | 1983-03-07 | 55 | 0 |
| K802856 | MINIATURE ION SELECTIVE ELECTRODES | Ionetics, Inc. | 1981-01-28 | 77 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda