Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Medical Systems Nederlands B.V. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
243 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240224 | Zenition 90 | Philips Medical Systems Nederlands B.V. | 2024-05-22 | 117 | 0 |
| K223442 | MR 5300 and MR 7700 R11 MR Systems | Philips Medical Systems Nederlands B.V. | 2022-12-23 | 39 | 3 |
| K201743 | ClarifEye R1.0, ClarifEye Needle | Philips Medical Systems Nederlands B.V. | 2021-02-23 | 243 | 0 |
| K181311 | Philips Hemodynamic Application R1.0 | Philips Medical Systems Nederlands B.V. | 2018-09-07 | 113 | 1 |
| K181966 | SmartPerfusion | Philips Medical Systems Nederlands B.V. | 2018-08-17 | 25 | 1 |
| K162025 | IntelliSpace Portal Platform | Philips Medical Systems Nederlands B.V. | 2016-10-18 | 88 | 0 |
| K153324 | Ingenia 1.5T and Ingenia 1.5T S R5.2 | Philips Medical Systems Nederlands B.V. | 2016-03-22 | 125 | 2 |
| K143128 | mDIXON XD | Philips Medical Systems Nederlands B.V. | 2015-03-20 | 141 | 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