510(k) Report

FDA applicant

Blackbriar Regulatory Services, LLC

Richmond, VA1 decision2021–20210 recalls

FDA records 1 decision for Blackbriar Regulatory Services, LLC (Richmond, VA) in 2021: 1 510(k) clearance. 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 Blackbriar Regulatory Services, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

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Which product codes does it file in?

  • FXXMask, Surgical1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K202824BRS Procedure Face MaskBlackbriar Regulatory Services, LLC · 20211cites it

What has FDA decided for it lately?

  • K202824BRS Procedure Face MaskBlackbriar Regulatory Services, LLC · 2021

The one decision as Blackbriar Regulatory Services, LLC →