Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Soterix Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
267 daysmedian FDA review time
681 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | 2026-02-20 | 267 | 0 |
| K233751 | Milieve (YPS-301BD) | Soterix Medical, Inc. | 2024-06-03 | 194 | 0 |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 1 | Soterix Medical, Inc. | 2024-03-25 | 94 | 0 |
| K192823 | MEGA-TMS | Soterix Medical, Inc. | 2021-08-13 | 681 | 0 |
| K191422 | Neural Navigator | Soterix Medical, Inc. | 2020-04-06 | 313 | 0 |
| K170291 | IontoDC | Soterix Medical, Inc. | 2017-05-01 | 90 | 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