Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Philips Electronics UK Limited — 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) |
|---|---|---|---|---|---|
| K101538 | HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) | Philips Electronics UK Limited | 2010-11-05 | 155 | 0 |
| K100495 | PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 | Philips Electronics UK Limited | 2010-06-22 | 123 | 0 |
| K090167 | PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01 | Philips Electronics UK Limited | 2009-06-18 | 147 | 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