# Splintek, Inc.

- Location (FDA's records): Lenexa, KS
- FDA decisions: 5 (2017–2025): 5 510(k) clearances
- Product codes: OBR (3), LRK (1), MQC (1)
- 510(k) review time since 2016: median 122 days, against 158 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 4 (3 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
- Power Products, Inc.-Splintek: 3 (https://510kreport.com/company/power-products-splintek)
- Akervall Technologies, Inc.: 2 (https://510kreport.com/company/akervall-technologies)
- Apnea Sciences Corporation: 1 (https://510kreport.com/company/apnea-sciences)
- Apnea Sciences Coporation: 1 (https://510kreport.com/company/apnea-sciences-coporation)

## Firms that cite its devices most
- Remvia: 1 (https://510kreport.com/company/remvia)

## Its most-cited devices
- K193577: SleepRight ProRx Custom Dental Guard (2020), cited by 2
- K172223: SleepRight ProRx Custom Dental Guard (2017), cited by 2

## Recent decisions
- K250122: SleepRight Snore Aid (May 19, 2025)
- K212767: SleepRight Select-Comfort Dental Guard (Dec 22, 2021)
- K212706: SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard (Dec 13, 2021)
- K193577: SleepRight ProRx Custom Dental Guard (Jun 1, 2020)
- K172223: SleepRight ProRx Custom Dental Guard (Nov 17, 2017)

Source page: https://510kreport.com/company/splintek