Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Ultrasound · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
265 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242519 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2025-05-15 | 265 | 1 |
| K242670 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2025-05-08 | 245 | 1 |
| K232500 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2023-10-26 | 70 | 1 |
| K223771 | Lumify Diagnostic Ultrasound System | Philips Ultrasound | 2023-05-04 | 139 | 2 |
| K040227 | QLAB QUANTIFICATION SOFTWARE | Philips Ultrasound | 2004-02-17 | 15 | 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