510(k) Report

FDA applicant

Kenneth Hilsen

New York, NY1 decision1998–19980 recalls

FDA records 1 decision for Kenneth Hilsen (New York, NY) in 1998: 1 510(k) clearance. All are in product code LRK (Device, Anti-Snoring). 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 Kenneth Hilsen’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kenneth Hilsen since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kenneth Hilsen 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

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.

  • K963591Snoring Control DeviceKenneth Hilsen · 19982cite it

What has FDA decided for it lately?

  • K963591Snoring Control DeviceKenneth Hilsen · 1998

The one decision as Kenneth Hilsen →

Other applicant names beginning “Kenneth”

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

Kenneth J. Hoek, M.D., Inc. 1Kenneth J. Purcell 1Kenneth Ullrich 1Kenneth Chapman 1