510(k) Report

FDA applicant

Premiumestore, LLC

Virginia Beach, VA2 decisions2021–20210 recalls

FDA records 2 decisions for Premiumestore, LLC (Virginia Beach, VA) in 2021: 2 510(k) clearances. All are in product code FXX (Mask, Surgical). 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, general and plastic surgery panel, where it files most

How often FDA has decided Premiumestore, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2021: 2
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Premiumestore, LLC by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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