Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Health Care · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
44 daysmedian FDA review time
183 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201352 | 3D Auto LAA | Philips Health Care | 2020-08-17 | 88 | 0 |
| K200974 | QLAB Advanced Quantification Software | Philips Health Care | 2020-06-03 | 51 | 0 |
| K200179 | Collaboration Live | Philips Health Care | 2020-02-18 | 25 | 0 |
| K191647 | QLAB Advanced Quantification Software | Philips Health Care | 2019-12-20 | 183 | 0 |
| K192226 | Lumify Diagnostic Ultrasound System | Philips Health Care | 2019-09-06 | 21 | 5 |
| K190913 | QLAB Advanced Quantification Software 13 | Philips Health Care | 2019-06-18 | 71 | 0 |
| K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnost | Philips Health Care | 2017-10-04 | 35 | 30 |
| K171314 | QLAB Advanced Quantification Software | Philips Health Care | 2017-05-30 | 26 | 0 |
| K163020 | Xperius Ultrasound System | Philips Health Care | 2016-11-16 | 16 | 1 |
| K162549 | Lumify Ultrasound System | Philips Health Care | 2016-10-03 | 20 | 6 |
| K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasou | Philips Health Care | 2016-09-14 | 26 | 2 |
| K153480 | ClearVue850 Diagnostic Ultrasound System | Philips Health Care | 2015-12-16 | 14 | 10 |
| K132087 | PERCUNAV SYSTEM | Philips Health Care | 2013-07-24 | 19 | 0 |
| K130159 | QLAB QUANTIFICATION SOFTWARE HEART MODEL | Philips Health Care | 2013-05-13 | 110 | 0 |
| K121498 | PERCUNAV | Philips Health Care | 2012-12-14 | 207 | 0 |
| K121638 | ST80I STRESS TEST SYSTEM | Philips Health Care | 2012-07-18 | 44 | 0 |
| K120855 | INTELLISPACE ECG | Philips Health Care | 2012-06-29 | 100 | 1 |
| K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM | Philips Health Care | 2012-02-17 | 15 | 8 |
| K112959 | CALG-STR EXERCISE ECG ANALYSIS ALGORITHM | Philips Health Care | 2012-01-26 | 114 | 0 |
| K110151 | ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T | Philips Health Care | 2011-03-22 | 63 | 15 |
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