Oxiplex
FDA 510(k) clearance K253326 · decided 2026-05-01
Clearance details
- K-number
- K253326
- Device name
- Oxiplex
- Applicant
- Fziomed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-30
- Decision date
- 2026-05-01
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- QVL
- Device class
- 2
- Regulation number
- 888.3047
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Luis Obispo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Oxiplex® (DEN240038) | Fziomed, Inc. | 2025-06-17 |
Recalls involving this device
No recalls on record reference this clearance.