Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alpha Omega Engineering , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
200 daysmedian FDA review time
236 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250601 | Neuro Omega System; NeuroSmart System | Alpha Omega Engineering , Ltd. | 2025-03-30 | 30 | 0 |
| K220553 | Neuro Omega System, NeuroSmart System | Alpha Omega Engineering , Ltd. | 2022-09-16 | 200 | 0 |
| K191739 | Sterile LeadConfirm | Alpha Omega Engineering , Ltd. | 2020-01-02 | 188 | 0 |
| K172042 | NeuroNav System, NeuroSmart System | Alpha Omega Engineering , Ltd. | 2018-02-27 | 236 | 0 |
| K171581 | Neuro Omega System | Alpha Omega Engineering , Ltd. | 2017-12-22 | 205 | 1 |
| K123796 | NEURO OMEGA SYSTEM | Alpha Omega Engineering , Ltd. | 2013-04-05 | 116 | 1 |
| K120098 | STERILE DISPOSABLES FOR MER | Alpha Omega Engineering , Ltd. | 2012-06-12 | 152 | 0 |
| K052527 | NEUROPROBES | Alpha Omega Engineering , Ltd. | 2006-04-12 | 212 | 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