510(k) Report

FDA applicant

Splintek, Inc.

Lenexa, KS5 decisions2017–20250 recalls

FDA records 5 decisions for Splintek, Inc. (Lenexa, KS) from 2017 to 2025: 5 510(k) clearances. Most are in product codes OBR (Mouthguard, Over-The-Counter) and LRK (Device, Anti-Snoring). Since 2016 its 510(k)s took a median of 122 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 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 Splintek, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12020: 12021: 22025: 1
2017high 2 (2021) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Splintek, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Splintek, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OBRMouthguard, Over-The-Counter3decisions
  • LRKDevice, Anti-Snoring1decision
  • MQCMouthguard, Prescription1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 122 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 158 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K193577SleepRight ProRx Custom Dental GuardSplintek, Inc. · 20202cite it
  • K172223SleepRight ProRx Custom Dental GuardSplintek, Inc. · 20172cite it

What has FDA decided for it lately?

  • K250122SleepRight Snore AidSplintek, Inc. · 2025
  • K212767SleepRight Select-Comfort Dental GuardSplintek, Inc. · 2021
  • K212706SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2021
  • K193577SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2020
  • K172223SleepRight ProRx Custom Dental GuardSplintek, Inc. · 2017

All 5 as Splintek, Inc. →