Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neurologica Corporation · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
199 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250928 | OmniTom Elite with PCD | Neurologica Corporation | 2025-09-08 | 164 | 0 |
| K233767 | OmniTom Elite | Neurologica Corporation | 2024-06-10 | 199 | 0 |
| K213649 | BodyTom 64 | Neurologica Corporation | 2022-04-29 | 161 | 0 |
| K171183 | OmniTom | Neurologica Corporation | 2017-08-18 | 116 | 1 |
| K142697 | NExCT 7 | Neurologica Corporation | 2014-12-23 | 92 | 0 |
| K102677 | BODYTOM NL 4000 | Neurologica Corporation | 2011-03-24 | 190 | 0 |
| K090811 | INSPIRA HD, MODEL: NL1000 | Neurologica Corporation | 2009-08-27 | 155 | 0 |
| K051765 | CERETOM, MODEL NL3000 | Neurologica Corporation | 2005-07-14 | 14 | 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