VaporShield
FDA 510(k) clearance K250847 · decided 2025-12-12
Clearance details
- K-number
- K250847
- Device name
- VaporShield
- Applicant
- Vault Paragon Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-20
- Decision date
- 2025-12-12
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- MEG
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Garden City, ID, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.