Data / Medical devices / Sleep Appliances With Patient Monitoring
Sleep Appliances With Patient Monitoring (PLC): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Sleep Appliances With Patient Monitoring (product code PLC, Class 2, 21 CFR 872.5570). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on August 25, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PLC
- Device class
- 2
- Regulation
- 872.5570
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Australia | 1 |
| Philippines | 1 |
| Thailand | 1 |
Makers of Sleep Appliances With Patient Monitoring
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Prosomnus Sleep Technologies | Pleasanton, CA, United States | Complaint file establishment, Manufacturer | 3 | April 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Somnomed Inc. | Plano, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | October 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Somnomed, Ltd. | CROWS NEST New South Wales, Australia | Specification developer | 2 | October 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| SomnoMed Phillipines Inc. | Makati City National Capital Region, Philippines | Manufacturer | 2 | October 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| GCDL, LLC | Prospect Heights, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexa Ceram Co., Ltd. | Sansai Chiang Mai, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Solutions LC | Lake Saint Louis, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.