510(k) Report

FDA applicant

Restore Medical, Inc.

Roseville, MN1 decision2004–20040 recalls

FDA records 1 decision for Restore Medical, Inc. (Roseville, MN) in 2004: 1 510(k) clearance. All are in product code 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 Restore Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Restore Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Restore Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • 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:

What has FDA decided for it lately?

  • K040417Pillar Palatal Implant SystemRestore Medical, Inc. · 2004

The one decision as Restore Medical, Inc. →

Other applicant names beginning “Restore”

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

Restore Surgical, LLC Dba Instratek 3Restore Medical Solutions, Inc. 1Restore Robotics 1