# K103704: Remotely Controlled Mandibular Positioner, RCMP

- Pathway: 510(k) (Abbreviated)
- Applicant: Zephyr Sleep Technologies, Inc.
- Decided: Mar 23, 2012 after 459 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: 8 generations back to K882303 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973884: Elastic Mandibular Advancement - Titration (Ema-T) Appilance, Frantz Design, Inc. (1998) Summary page 3.
- K043330: Polypropilene Surgical Sutures, Demetech Corp. (2005) Summary page 1.
- K111110: Apnea Guard, Advanced Brain Monitoring, Inc. (2011). Cleared while this submission was under review

## Indications for use
Overnight use of a temporary oral appliance to determine in which patients with obstructive sleep apnea mandibular advancement by an oral appliance will reduce obstruction of airflow and thereby to identify patients suitable for oral appliance therapy. The device is also used to recommend a target mandibular position that will reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy.

Source page: https://510kreport.com/device/K103704
Methodology: https://510kreport.com/methodology