# K991209: Oral Sleep Disorder Aid

- Pathway: 510(k) (Traditional)
- Applicant: Perl-Rad Sleep Disorder Lab
- Decided: Sep 22, 1999 after 166 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K870611: Charles F. Samelson. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K870871: Victor Gardy. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure. The device is intended for use as an aid to reduce simple snoring. It is customized for patients with or without natural teeth and for mixed dentition. Reflex action reverts to mouth breathing instantly should the nasal passages congest

Source page: https://510kreport.com/device/K991209
Methodology: https://510kreport.com/methodology