510(k) clearance
TruPress
- 510(k) number
- K254074
- Applicant
- Procerus Enterprises
- Decision date
- Sep 10, 2026
- Date received
- Dec 18, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DRS
- Device type
- Transducer, Blood-Pressure, Extravascular
- Device class
- Class II
- Regulation
- 21 CFR 870.2850
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Salt Lake City, UT, US