OTOPLAN
FDA 510(k) clearance K220300 · decided 2022-06-24
Clearance details
- K-number
- K220300
- Device name
- OTOPLAN
- Applicant
- Cascination AG
- Decision
- Substantially Equivalent
- Date received
- 2022-02-02
- Decision date
- 2022-06-24
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- QQE
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bern, CH
- 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 |
|---|---|---|
| OTOPLAN (K242120) | Cascination AG | 2025-04-11 |
| Otoplan (K203486) | Cascination AG | 2021-08-20 |
Recalls involving this device
No recalls on record reference this clearance.