510(k) K254074
K254074 is an FDA 510(k) premarket notification submitted by Procerus Enterprises for the device "TruPress". The FDA issued a decision of Substantially Equivalent on September 10, 2026. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2026
- Date Received
- December 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type