510(k) Report

FDA applicant

Boyd Research, Inc.

Solana Beach, CA2 decisions2020–20210 recalls

FDA records 2 decisions for Boyd Research, Inc. (Solana Beach, CA) from 2020 to 2021: 2 510(k) clearances. All are in product code OBR (Mouthguard, Over-The-Counter). No recall is linked to its devices.

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

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

FDA decisions per year

1in 2021

2020: 12021: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Boyd Research, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OBRMouthguard, Over-The-Counter2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K211158NTI ClenchGuardBoyd Research, Inc. · 20212cite it

What has FDA decided for it lately?

  • K211158NTI ClenchGuardBoyd Research, Inc. · 2021
  • K181005ClenchGuardBoyd Research, Inc. · 2020

All 2 as Boyd Research, Inc. →

Other applicant names beginning “Boyd”

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

Boyd Industries, Inc. 2