# K200657: SmartGuard Anti-Snoring Device

- Pathway: 510(k) (Traditional)
- Applicant: Smartguard Rx, Inc.
- Decided: Aug 23, 2021 after 529 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: 6 generations back to K071404 (2007). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170825: SnoreRx, Apnea Sciences Corporation (2017). Our reading of the summary gave K170285, FDA’s number for AED Sinuscope (National Advanced Endoscopy Devices, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “SnoreRx”. Summary page 7.

## Most influential descendants
- K250353: Oniris; Oniris Plus (2025), 0 descendants of its own
- K231138: Aniti-Snore Mouthguard+ (2024), 0 descendants of its own

## Indications for use
SmartGuard Anti-Snore Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring.

Source page: https://510kreport.com/device/K200657
Methodology: https://510kreport.com/methodology