FDA applicant

Sleeping Well, LLC

Shelburne, VT6 decisions2009–20220 recalls

FDA records 6 decisions for Sleeping Well, LLC (Shelburne, VT) from 2009 to 2022: 6 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Its devices cite 8 predicates, 4 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 Sleeping Well, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Sleeping Well, LLC by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Sleeping Well, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?