# K113201: Narval CC

- Pathway: 510(k) (Abbreviated)
- Applicant: Resmed Sas
- Decided: Dec 1, 2011 after 31 days
- Product code: LQZ (Device, Jaw Repositioning)
- Device class: 2
- Regulation: 21 CFR 872.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K882303 (1989). 8 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 1.
- K971794: Elastic Mandibular Advancement (Ema) Appliance, Frantz Design, Inc. (1997) Summary page 1.

## Most influential descendants
- K143244: The Panthera Anti-Snoring Device (2014), 9 descendants of its own
- K153291: Sicat Optisleep (2016), 3 descendants of its own
- K203596: Panthera Occlusal Appliance (2021), 2 descendants of its own
- K232025: Hushd Pro Avera (2024), 1 descendant of its own
- K230495: Serena Sleep Night Guard (2023), 1 descendant of its own

## Indications for use
The Narval CC™ is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K113201
Methodology: https://510kreport.com/methodology