# K191320: Slow Wave DS8

- Pathway: 510(k) (Traditional)
- Applicant: Slow Wave, Inc.
- Decided: Oct 2, 2020 after 506 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: 10 generations back to K882303 (1989). 18 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192581: The NightBlocks Appliance, Advanced Facialdontics, LLC (2020). Cleared while this submission was under review Summary page 4.

## Cited in the summary but kept off the family tree
- K142344: DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System, Izi Medical Products, LLC (2015). Our reading of the summary gave K142344, FDA’s number for DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation… (Izi Medical Products, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “Panthera D-SAD”. Kept off the family tree. Summary page 4.

## Most influential descendants
- K233754: AIO Breathe (2024), 1 descendant of its own
- K230532: RADx Intraoral Appliance for Snoring and Sleep Apnea (2023), 1 descendant of its own
- K254304: iNOS intraoral biosensor (2026), 0 descendants of its own
- K252525: AIO Breathe (2025), 0 descendants of its own
- K220330: Soundly Anti Snoring Device (2022), 0 descendants of its own

## Indications for use
Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.

Source page: https://510kreport.com/device/K191320
Methodology: https://510kreport.com/methodology