Paptizer 360
FDA 510(k) clearance K252471 · decided 2026-04-29
Clearance details
- K-number
- K252471
- Device name
- Paptizer 360
- Applicant
- LiViliti Health Products Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-08-06
- Decision date
- 2026-04-29
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- QXQ
- Device class
- 2
- Regulation number
- 880.6993
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake City, FL, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| SoClean 3+ (K243815) | Soclean, Inc. | 2025-10-10 |
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Recalls involving this device
No recalls on record reference this clearance.