SoClean 3+
FDA 510(k) clearance K243815 · decided 2025-10-10
Clearance details
- K-number
- K243815
- Device name
- SoClean 3+
- Applicant
- Soclean, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-11
- Decision date
- 2025-10-10
- Days to decision
- 303 days
- Clearance type
- Traditional
- Product code
- QXQ
- Device class
- 2
- Regulation number
- 880.6993
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Peterborough, NH, 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 |
|---|---|---|
| Paptizer 360 (K252471) | LiViliti Health Products Corporation | 2026-04-29 |
| SoClean 3+ Bacterial Reduction Device (DEN210037) | Soclean, Inc. | 2024-08-12 |
Recalls involving this device
No recalls on record reference this clearance.