510(k) Report

FDA applicant

Meris Investment Group

Lakeland, MN2 decisions2021–20230 recalls

FDA records 2 decisions for Meris Investment Group (Lakeland, MN) from 2021 to 2023: 2 510(k) clearances. Most are in product codes MQC (Mouthguard, Prescription) and LRK (Device, Anti-Snoring). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, dental panel, where it files most

How often FDA has decided Meris Investment Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12023: 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 — Meris Investment Group 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?

  • MQCMouthguard, Prescription1decision
  • LRKDevice, Anti-Snoring1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)Meris Investment Group · 20212cite it
  • K230495Serena Sleep Night GuardMeris Investment Group · 20231cites it

What has FDA decided for it lately?

  • K230495Serena Sleep Night GuardMeris Investment Group · 2023
  • K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)Meris Investment Group · 2021

All 2 as Meris Investment Group →