Identity
- Trade Name
- O2Vent Optima FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions. FDA UDI
- Model / Reference
- O2Vent Optima FDA UDI
- Description
- The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09351567000035 FDA UDI
- 510(k) Number
- K190236 FDA UDI
- FDA Product Code
- LRK FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
O2Vent Optima by Oventus Manufacturing Pty, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mandible-repositioning sleep-disordered breathing orthosis.
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Cleared under the same submission
K190236 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Oventus Manufacturing Pty, Ltd.
Sources (1)
- FDA UDI b5791608-232f-46c4-8496-f802f092f1ae 34 fields · synced Jun 6, 2026