510(k) Report

FDA applicant

Paragon Trade Brands, Inc.

Federal Way, WA14 decisions1995–19980 recalls

FDA records 14 decisions for Paragon Trade Brands, Inc. (Federal Way, WA) from 1995 to 1998: 14 510(k) clearances. Most are in product codes HHD (Pad, Menstrual, Unscented) and HEB (Tampon, Menstrual, Unscented). No 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 Paragon Trade Brands, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Paragon Trade Brands, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Paragon”

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