Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Evenflo Company, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
103 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102600 | SIMPLYGO BREAST PUMP | Evenflo Company, Inc. | 2010-12-22 | 103 | 0 |
| K100435 | AMEDA PLATINUM BREAST PUMP | Evenflo Company, Inc. | 2010-05-28 | 101 | 0 |
| K092770 | SIMPLYGO HANDS FREE BREAST PUMP | Evenflo Company, Inc. | 2009-10-09 | 30 | 0 |
| K082307 | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT | Evenflo Company, Inc. | 2008-09-11 | 29 | 0 |
| K053493 | BERRY FRUITY TEETHER | Evenflo Company, Inc. | 2006-02-22 | 69 | 0 |
| K052909 | EVENFLO ELAN BREAST PUMP | Evenflo Company, Inc. | 2005-11-01 | 15 | 0 |
| K022933 | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT | Evenflo Company, Inc. | 2002-12-02 | 89 | 0 |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Evenflo Company, Inc. | 2001-12-20 | 84 | 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