# K162816: SML-OSA2 Appliances

- Pathway: 510(k) (Traditional)
- Applicant: Selane Products, Inc.
- Decided: Jul 27, 2017 after 294 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: 9 generations back to K882303 (1989). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130130: Atg/SM-Osa Appliances, Selane Products, Inc. (2013) Summary page 4.

## Indications for use
The SML-OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.

Source page: https://510kreport.com/device/K162816
Methodology: https://510kreport.com/methodology