Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifewatch Technologies , 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) |
|---|---|---|---|---|---|
| K151835 | Vital Signs Patch System | Lifewatch Technologies , Ltd. | 2016-02-05 | 214 | 0 |
| K151269 | ECG Mini System Continuous ECG Monitor and Arrhythmia Detect | Lifewatch Technologies , Ltd. | 2016-01-15 | 247 | 0 |
| K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detecto | Lifewatch Technologies , Ltd. | 2015-09-11 | 291 | 0 |
| K132407 | VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) | Lifewatch Technologies , Ltd. | 2014-12-19 | 504 | 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