Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifelines , Ltd. — 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) |
|---|---|---|---|---|---|
| K172271 | Trackit T4 EEG Amplifier | Lifelines , Ltd. | 2018-05-04 | 280 | 0 |
| K151600 | R-40 EEG Amplifier | Lifelines , Ltd. | 2015-10-23 | 133 | 0 |
| K101691 | LIFELINES PHOTIC STIMULATOR | Lifelines , Ltd. | 2010-08-10 | 55 | 0 |
| K010460 | LIFELINES TRACKIT | Lifelines , Ltd. | 2001-05-14 | 87 | 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