# K203477: Classic

- Pathway: 510(k) (Traditional)
- Applicant: Orthoapnea S.L.
- Decided: Feb 25, 2021 after 90 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: 7 generations back to K882303 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060388: Tap II Anti-Snoring and Obstructive Sleep Apnea Oral Appliance with Attachment, Airway Management, Inc. (2006) Summary page 4.
- K062951: Tap Iii Anti-Snoring Device, Airway Management, Inc. (2006) Summary page 4.

## Indications for use
Classic is a Mandibular Advancement Device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

Source page: https://510kreport.com/device/K203477
Methodology: https://510kreport.com/methodology