Evenflo Company, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Evenflo Company, Inc.” (first 2001, latest 2010), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 6 | 6 |
| HGY | Pump, Breast, Non-Powered | 1 | 1 |
| KKO | Ring, Teething, Fluid-Filled | 1 | 1 |
Review panels
- Obstetrics and Gynecology (7)
- Dental (1)
Most recent Evenflo Company, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102600 | SIMPLYGO BREAST PUMP | HGX | 2010-12-22 | 103 |
| K100435 | AMEDA PLATINUM BREAST PUMP | HGX | 2010-05-28 | 101 |
| K092770 | SIMPLYGO HANDS FREE BREAST PUMP | HGX | 2009-10-09 | 30 |
| K082307 | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT | HGX | 2008-09-11 | 29 |
| K053493 | BERRY FRUITY TEETHER | KKO | 2006-02-22 | 69 |
| K052909 | EVENFLO ELAN BREAST PUMP | HGX | 2005-11-01 | 15 |
| K022933 | EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT | HGX | 2002-12-02 | 89 |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | HGY | 2001-12-20 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Evenflo Company, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Evenflo Co., Inc. (3 510(k)s)
- Evenflo Feeding, Inc. (1 510(k)s)
- Evenflo Feeding Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Evenflo Company, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Evenflo Company, Inc.” (first 2001, latest 2010), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Evenflo Company, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Evenflo Company, Inc. is 76 days.
Which FDA product codes appear under Evenflo Company, Inc.?
The most frequent FDA product codes under this applicant name are HGX (Pump, Breast, Powered, 6); HGY (Pump, Breast, Non-Powered, 1); KKO (Ring, Teething, Fluid-Filled, 1).
Next steps
- See all 8 Evenflo Company, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Evenflo Company, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.