Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifesignals, Inc. — 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) |
|---|---|---|---|---|---|
| K261569 | UbiqVue™ 2AYe Cardiac System (UX2253) | Lifesignals, Inc. | 2026-07-09 | 58 | 0 |
| K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024-11-12 | 125 | 0 |
| K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | 2021-07-21 | 296 | 0 |
| K200690 | LifeSignals ECG Remote Monitoring Patch Platform | Lifesignals, Inc. | 2020-07-15 | 121 | 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