# K113516: Therasom-Cast

- Pathway: 510(k) (Traditional)
- Applicant: Family Dental Services, P.C.
- Decided: Jan 4, 2013 after 402 days
- Product code: LRK (Device, Anti-Snoring)
- 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). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971794: Elastic Mandibular Advancement (Ema) Appliance, Frantz Design, Inc. (1997) Summary page 1.
- K955503: Adjustable PM Positioner, Jonathan A. Parker, D.D.S. (1996) Summary page 1.
- K950763: Lowe Klearway, Dr. Alan A. Lowe, Inc. (1995) Summary page 1.
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 1.

## Most influential descendants
- K170053: Meridian PM (2017), 0 descendants of its own
- K150941: Somnowell Mandibular Advancement Appliance (MAA) (2015), 0 descendants of its own

## Indications for use
The TheraSom-CAST is used to reduce or alleviate the occurrence of snoring and/or for the treatment of mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.

Source page: https://510kreport.com/device/K113516
Methodology: https://510kreport.com/methodology