FDA applicant

Evenflo Company, Inc.

Miamisburg, OH11 decisions1996–20101 recall

FDA records 11 decisions for Evenflo Company, Inc. (Miamisburg, OH) from 1996 to 2010: 11 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and KKO (Ring, Teething, Fluid-Filled). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Evenflo Co., Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Evenflo Company, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Evenflo Company, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Evenflo Company, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Evenflo”

FDA records each applicant name separately; these may or may not be the same firm.

Evenflo Feeding, Inc. 2

Evenflo Company, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

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Other applicant names beginning “Evenflo”