Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Phillips Medical Systems — 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) |
|---|---|---|---|---|---|
| K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015-09-29 | 92 | 0 |
| K103646 | INTELLIVUE MX40 PATIENT MONITOR | Phillips Medical Systems | 2011-01-07 | 24 | 1 |
| K080548 | HD7 DIAGNOSTIC ULTRASOUND SYSTEM | Phillips Medical Systems | 2008-03-27 | 28 | 0 |
| K041942 | M2376A DEVICELINK SYSTEM | Phillips Medical Systems | 2004-07-23 | 4 | 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