Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neurodiagnostics, 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) |
|---|---|---|---|---|---|
| K843253 | EMG/NCV & EVOKED RESPONSE, DESIGN W/ | Neurodiagnostics, Inc. | 1984-11-20 | 92 | 0 |
| K830191 | NEURO DIAGNOSTICS MODEL FCR | Neurodiagnostics, Inc. | 1983-02-18 | 29 | 0 |
| K801670 | NDI-IKE EMG | Neurodiagnostics, Inc. | 1980-08-04 | 13 | 0 |
| K801671 | ESG-1 (EVOKED RESPONSE STIMULUS GENER) | Neurodiagnostics, Inc. | 1980-08-04 | 13 | 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