510(k) Report

FDA applicant

Koncept Innovators, LLC

Myrtle Beach, SC3 decisions2019–20260 recalls

FDA records 3 decisions for Koncept Innovators, LLC (Myrtle Beach, SC) from 2019 to 2026: 3 510(k) clearances. Most are in product codes LRK (Device, Anti-Snoring) and OBR (Mouthguard, Over-The-Counter). Since 2016 its 510(k)s took a median of 172 days from receipt to decision, against 80 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Koncept Innovators, Inc.”.

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 Koncept Innovators, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2019: 12020: 12026 (partial year): 1
2019high 1 (2019) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Koncept Innovators, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • LRKDevice, Anti-Snoring2decisions
  • OBRMouthguard, Over-The-Counter1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 172 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 80 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K181099Bright GuardKoncept Innovators, LLC · 20192cite it
  • K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC · 20201cites it

What has FDA decided for it lately?

  • K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc. · 2026
  • K201484Somnos Anti-Snoring Mouth GuardKoncept Innovators, LLC · 2020
  • K181099Bright GuardKoncept Innovators, LLC · 2019

All 2 as Koncept Innovators, LLC →The one decision as Koncept Innovators, Inc. →