FDA applicant

Playtex Products, Inc.

Allendale, NJ17 decisions1995–20081 recall

FDA records 17 decisions for Playtex Products, Inc. (Allendale, NJ) from 1995 to 2008: 17 510(k) clearances. Most are in product codes HIL (Tampon, Menstrual, Scented, Scented-Deodorized) and HEB (Tampon, Menstrual, Unscented). Its devices cite 22 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.

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 Playtex Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Playtex Products, 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 “Playtex”

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

Playtex, Inc. 20 Playtex Family Products, Inc. 17 Playtex Manufacturing, Inc. 3

Playtex Products, 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?

What has been recalled?

Other applicant names beginning “Playtex”