Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifeline Systems, 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) |
|---|---|---|---|---|---|
| K103214 | M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 | Lifeline Systems, Inc. | 2010-12-01 | 30 | 0 |
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM | Lifeline Systems, Inc. | 1991-09-27 | 15 | 3 |
| K834441 | BLOOD PRESSURE MONITOR BP600X | Lifeline Systems, Inc. | 1984-05-21 | 157 | 0 |
| K831638 | SINGLE BED ARRHYTHMIA MONITOR AM500 | Lifeline Systems, Inc. | 1983-11-14 | 175 | 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