Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prothia USA, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
108 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831071 | UNIVERSAL INSTRU. SET FOR NEUROVASCULAR | Prothia USA, Inc. | 1983-06-08 | 65 | 0 |
| K830993 | AMPLIGREFFE | Prothia USA, Inc. | 1983-05-03 | 35 | 0 |
| K823581 | ELPHA 500 | Prothia USA, Inc. | 1983-03-24 | 108 | 0 |
| K830058 | MYOGRAPH 2000 | Prothia USA, Inc. | 1983-03-07 | 59 | 0 |
| K823583 | MYOTEST NERVE STIMULATOR | Prothia USA, Inc. | 1982-12-30 | 24 | 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