# Koncept Innovators, LLC

- Location (FDA's records): Myrtle Beach, SC
- FDA decisions: 3 (2019–2026): 3 510(k) clearances
- Names in FDA's records: Koncept Innovators, LLC (2); Koncept Innovators, Inc. (1)
- Product codes: LRK (2), OBR (1)
- 510(k) review time since 2016: median 172 days, against 80 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Apnea Sciences Corporation: 1 (https://510kreport.com/company/apnea-sciences)
- Grind Guard Technologies, LLC: 1 (https://510kreport.com/company/grind-guard-technologies)

## Firms that cite its devices most
- Fbcc, Inc.: 1 (https://510kreport.com/company/fbcc)
- Xiamen Yizhou Imp. & Exp. Co., Ltd.: 1 (https://510kreport.com/company/xiamen-yizhou-imp-exp)

## Its most-cited devices
- K181099: Bright Guard (2019), cited by 2
- K201484: Somnos Anti-Snoring Mouth Guard (2020), cited by 1

## Recent decisions
- K261134: Dormiva Anti-Snoring Mouth Guard (May 14, 2026)
- K201484: Somnos Anti-Snoring Mouth Guard (Nov 23, 2020)
- K181099: Bright Guard (Jan 18, 2019)

Source page: https://510kreport.com/company/koncept-innovators