510(k) Report

FDA applicant

Restore Medical Solutions, Inc.

Chevy Chase, MD1 decision2013–20130 recalls

FDA records 1 decision for Restore Medical Solutions, Inc. (Chevy Chase, MD) in 2013: 1 510(k) clearance. All are in product code KCT (Sterilization Wrap Containers, Trays…). Its devices cite 2 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, general hospital panel, where it files most

How often FDA has decided Restore Medical Solutions, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Restore Medical Solutions, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 20131cites it

What has FDA decided for it lately?

  • K131455Restore Modular Sterilization Tray SystemRestore Medical Solutions, Inc. · 2013

The one decision as Restore Medical Solutions, 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, Inc. 1Restore Robotics 1