# K033822: Respironics Custom I Oral Appliance

- Pathway: 510(k) (Special)
- Applicant: Respironics, Inc.
- Decided: Feb 6, 2004 after 58 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: 1 generation back to K954530 (1995). 1 ancestor in all.
35 later devices descend from it; 4 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954530: The Silencer, Silent Knights Ventures, Inc. (1995) Summary page 1.

## Most influential descendants
- K061688: Anti-Snoring / Sleep Apnea Device (2006), 22 descendants of its own
- K090503: Zquiet Mouthpiece (2009), 10 descendants of its own
- K093407: Zquiet Mouthpiece (2010), 8 descendants of its own
- K180124: ZQuiet (2018), 6 descendants of its own
- K111680: DR. Greensburg's Hybrid (2011), 6 descendants of its own

## Indications for use
The Respironics Custom I Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring and obstructive sleep apnea.

Source page: https://510kreport.com/device/K033822
Methodology: https://510kreport.com/methodology