FDA product code PLC: Sleep Appliances With Patient Monitoring
PLC is the FDA product code for sleep appliances with patient monitoring. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel. FDA has cleared 10 510(k) submissions under PLC, 3 in the last five years, from 9 different applicants. The average 510(k) review took 231 days (median 228); 283 days on average over the last three years.
Definition
For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
Classification
| Field | Value |
|---|---|
| Device name | Sleep Appliances With Patient Monitoring |
| Device class | Class II |
| Regulation | 21 CFR 872.5570 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PLC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 162 |
| 2019 | 1 | 309 |
| 2020 | 1 | 420 |
| 2024 | 1 | 338 |
| 2026 | 2 | 228 |
Compare with all 510(k) review times · Search every PLC clearance
Top PLC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Somnomed, Inc. | 2 | 2024-10-03 |
| Achaemenid, LLC | 1 | 2026-08-25 |
| Prosomnus Sleep Technologies | 1 | 2026-04-06 |
| Residential Home Sleep Services | 1 | 2020-04-10 |
| Mark Abramson, D.D.S., Inc. | 1 | 2019-04-19 |
4 more applicants have PLC clearances. See the full list in Caduvo.
Most recent PLC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254304 | Achaemenid, LLC | iNOS intraoral biosensor | 2026-08-25 | 237 |
| K252765 | Prosomnus Sleep Technologies | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | 2026-04-06 | 220 |
| K233497 | Somnomed, Inc. | Rest Assure System | 2024-10-03 | 338 |
| K190353 | Residential Home Sleep Services | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | 2020-04-10 | 420 |
| K181571 | Mark Abramson, D.D.S., Inc. | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | 2019-04-19 | 309 |
Recalls for PLC devices
openFDA lists no recalls for product code PLC.
Frequently asked questions
What is FDA product code PLC?
PLC is the FDA product code for sleep appliances with patient monitoring. It is a Class II device, regulated under 21 CFR 872.5570 and reviewed by the Dental panel.
What device class is PLC?
Class II, regulation 21 CFR 872.5570. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLC?
Across 10 cleared submissions the average was 231 days from receipt to decision (median 228).
Which companies have the most PLC clearances?
Somnomed, Inc. (2); Achaemenid, LLC (1); Prosomnus Sleep Technologies (1); Residential Home Sleep Services (1); Mark Abramson, D.D.S., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PLC
- Run a recall and safety report across every PLC manufacturer
- Watch product code PLC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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