Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neuroscience, 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) |
|---|---|---|---|---|---|
| K871931 | ISTAT SOFTWARE | Neuroscience, Inc. | 1987-10-13 | 147 | 0 |
| K870263 | NEUROMAPPER 1620 | Neuroscience, Inc. | 1987-04-10 | 77 | 0 |
| K855232 | SOMATOSENSORY EVOKED POTENTIAL STIMULATOR | Neuroscience, Inc. | 1986-07-03 | 185 | 0 |
| K850430 | NEUROSCIENCE MAP-10 EEG | Neuroscience, Inc. | 1985-07-17 | 163 | 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