510(k) Report

FDA applicant

Nti-Tss, Inc.

Mishawaka, IN2 decisions2001–20050 recalls

FDA records 2 decisions for Nti-Tss, Inc. (Mishawaka, IN) from 2001 to 2005: 2 510(k) clearances. Most are in product codes OCO (Mouthguard, Migraine/Tension Headache) and 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 Nti-Tss, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nti-Tss, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nti-Tss, 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?

  • OCOMouthguard, Migraine/Tension Headache1decision
  • LRKDevice, Anti-Snoring1decision

Who builds on its devices?

Later devices cite its devices 6 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.

  • K010876Nti Tension Suppression SystemNti-Tss, Inc. · 20016cite it

What has FDA decided for it lately?

  • K041184Nti Tension Suppression System, with a Snorehook ApplicationNti-Tss, Inc. · 2005
  • K010876Nti Tension Suppression SystemNti-Tss, Inc. · 2001

All 2 as Nti-Tss, Inc. →