Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neotonus, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002889 | PNS MAGNETIC STIMULATOR SYSTEM | Neotonus, Inc. | 2001-04-06 | 203 | 0 |
| K001903 | NEOCONTROL PELVIC FLOOR THERAPY SYSTEM | Neotonus, Inc. | 2000-08-29 | 68 | 0 |
| K973096 | NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM | Neotonus, Inc. | 1998-06-12 | 297 | 0 |
| K973929 | NEOTONUS MS-101 MAGNETIC MUSCLE STIMULATOR SYSTEM | Neotonus, Inc. | 1998-05-21 | 218 | 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