Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Natus Manufacturing Limited · 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) |
|---|---|---|---|---|---|
| K242346 | Grass® MR Conditional/CT Cup Electrodes | Natus Manufacturing Limited | 2024-08-29 | 22 | 0 |
| K173815 | Allergan Botox Needle Electrode | Natus Manufacturing Limited | 2018-06-29 | 196 | 0 |
| K161430 | Myoject Luer Lock Needle Electrode | Natus Manufacturing Limited | 2017-03-02 | 283 | 0 |
| K143433 | Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dan | Natus Manufacturing Limited | 2015-08-28 | 270 | 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