Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Consumer Lifestyle - Innovation Site Eindhoven · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203383 | Philips Avent Double electric breast pump Advanced SCF394/61 | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2020-12-15 | 28 | 0 |
| K201381 | Philips Avent Single/Double electric breast pump Advanced | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2020-10-01 | 128 | 0 |
| K161532 | Philips Avent Comfort Single/Twin Electric Breast Pump | Philips Consumer Lifestyle - Innovation Site Eindhoven | 2016-08-29 | 88 | 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