Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Evenflo Co., Inc. — 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) |
|---|---|---|---|---|---|
| K983776 | EVENFLO COMFORT CONTROL BREAST PUMP, EVENFLO COMFORT CONTROL | Evenflo Co., Inc. | 1999-04-26 | 182 | 0 |
| K960727 | EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT | Evenflo Co., Inc. | 1997-02-14 | 358 | 0 |
| K960726 | EVENFLO SOFT-TOUCH ULTRA BATTERY OPERATED BREAST PUMP | Evenflo Co., Inc. | 1996-07-22 | 151 | 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