Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neurophet., Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
174 daysmedian FDA review time
448 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252563 | Neurophet SCALE PET | Neurophet., Inc. | 2026-05-15 | 274 | 0 |
| K261273 | Neurophet AQUA | Neurophet., Inc. | 2026-05-15 | 28 | 0 |
| K252496 | Neurophet AQUA AD Plus | Neurophet., Inc. | 2026-01-29 | 174 | 0 |
| K242215 | Neurophet AQUA (V3.1) | Neurophet., Inc. | 2024-10-25 | 88 | 0 |
| K220437 | Neurophet AQUA | Neurophet., Inc. | 2023-05-10 | 448 | 0 |
| K221405 | Neurophet SCALE PET | Neurophet., Inc. | 2022-08-05 | 81 | 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