Manufacturer registered with FDA
Apnea Sciences Corporation
Henderson, NV, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 22016–2017
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Apnea Sciences Corporation as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Apnea Sciences Corporation | 2 clearances | 2016–2017 | Below |
| Australia | TGA | Manufacturer | Apnea Sciences Corporation | 1 | 2019–2019 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | APNEA SCIENCES CORPORATION | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Apnea Sciences Corporation | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Apnea Sciences Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | ApneaRxSleep SilentSnoreMDSnoreRx | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Apnea Sciences Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Apnea Science Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Mar 2012 | K113569 | APNEARX | Apnea Science Corporation | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| APNEA SCIENCES CORPORATIONFDA reg. 3009549393 | Henderson, NV, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10040279). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.