TruPress— 510(k) K254074
Substantially EquivalentProcerus Enterprises
FDA 510(k) clearance K254074 for TruPress, Substantially Equivalent on 2026-09-10. Applicant: Procerus Enterprises. Device class: 2.
Summary
TruPress is filed under DRS, extravascular blood pressure transducers. The record doesn't describe the device further.
Class II, 21 CFR 870.2850. The Cardiovascular panel reviewed it as a Traditional 510(k).
Procerus Enterprises filed from Salt Lake City, Utah. Review took 266 days (December 18, 2025 to September 10, 2026).
Clearance details
- Applicant
- Procerus Enterprises
- Product code
- Product code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code DRS
view all- K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K161408 — Compass Cast and MAP
Adverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.