Identity
- Trade Name
- iNAP One FDA UDI
- Generic Name
- Intraoral negative-pressure sleep apnoea unit FDA UDI
- Device Name
- iNAP One Quarterly Kit FDA UDI
- Model / Reference
- Quarterly Kit FDA UDI
- Description
- iNAP One Quarterly Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719878320887 FDA UDI
- 510(k) Number
- K193460 FDA UDI
- FDA Product Code
- OZR FDA UDI
- GMDN Term
- Intraoral negative-pressure sleep apnoea unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intraoral negative-pressure sleep apnoea unit
iNAP One by Somnics, Inc. — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intraoral negative-pressure sleep apnoea unit.
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- iNAP One — SOMNICS, INC. · Class II
- iNAP — SOMNICS, INC. · Class II
- iNAP — SOMNICS, INC. · Class II
- iNAP — SOMNICS, INC. · Class II
- iNAP One — SOMNICS, INC. · Class II
Cleared under the same submission
K193460 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Somnics, Inc.
Sources (2)
- FDA UDI 9b360f74-8e2a-40f1-b71f-ef407e331c2d 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026