Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The First Years, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K032845 | EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 | The First Years, Inc. | 2004-04-05 | 207 | 0 |
| K033131 | NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST PUMP, MODEL 1 | The First Years, Inc. | 2003-10-30 | 30 | 0 |
| K032566 | NATURAL COMFORT BATTERY/ELECTRIC BREAST PUMP | The First Years, Inc. | 2003-09-15 | 25 | 0 |
| K964403 | SIMPLICITY TM ELECTRIC/BATTERY BREAST PUMP KIT (1068) | The First Years, Inc. | 1997-01-13 | 70 | 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