# K023836: The Suad Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Strong Dental, Inc.
- Decided: Jul 8, 2003 after 232 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 K955822 (1996). 1 ancestor in all.
11 later devices descend from it; 4 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)
- K955822: Removable Herbst Appliance, Univ. Dental Assoc. Department of Orthodontics (1996) Summary page 1.

## Most influential descendants
- K131138: Respire Pink Series - Herbst (2013), 7 descendants of its own
- K150572: Respire Pink Series-Herbst-EF (2015), 5 descendants of its own
- K170692: Respire Pink Series with DentiTrac (2017), 2 descendants of its own
- K192127: Respire Pink AT (Hard, Hard/Soft, EF) (2020), 1 descendant of its own
- K223624: Emerald Herbst (2023), 0 descendants of its own

## Indications for use
A custom-fitted mandibular repositioning device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea. Contraindications: The device is contraindicated for patients who: Have central sleep apnea Have severe respiratory disorders Have an edentulous arch Have loose teeth or advanced periodontal disease Are under 18 years of age.

Source page: https://510kreport.com/device/K023836
Methodology: https://510kreport.com/methodology