510(k) clearances

TruPress

Procerus Enterprises · Cardiovascular

K254074Substantially EquivalentTraditionalDRS
Open FDA's page for this record
Third party flag
N
City
Salt Lake City
Advisory committee description
Cardiovascular
Address 1
2505 E. 3300 S
Address 2
Suite 202
Statement or summary
Summary
Product code
DRS
Zip code
84124
Applicant
Procerus Enterprises
Decision date
2026-09-10
Decision code
SESE
Country code
US
Device name
TruPress
Advisory committee
CV
Contact
Jordan Cox
K number
K254074
State
UT
Date received
2025-12-18
Review advisory committee
CV
Postal code
84124
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Transducer, Blood-Pressure, Extravascular
Medical specialty description
Cardiovascular
Regulation number
870.2850
Device class
2
Registration number
1417592, 3005580113, 8043969, 3012542015, 3004111573, 1423395, 3010421104, 1718873, 3007836437, 9612152, 1218950, 3003263092, 3004605321, 3009001657, 3015309643, 3013596024, 3005012805, 3006891665, 8020616, 1713468, 1018233, 3005941719, 3004519921, 3033589330, 3015225571, 1724474, 9616088, 3008496528, 3011237704, 3016618143, 3012536737, 9615817, 1061124, 2246552, 1721504, 9610816, 3015910259, 3040153768, 8010042, 2648727 +48 more
FEI number
1417592, 3005580113, 3003081151, 3012542015, 1000514656, 3004111573, 3003807466, 3010421104, 1718873, 3001665800, 3016261803, 3007836437, 1218950, 3003263092, 3004605321, 3009001657, 3015309643, 3013596024, 3005012805, 1000112877, 3006891665, 1000512168, 1713468, 3005846326, 3002806476, 1018233, 3033589330, 3015225571, 3008496528, 3011237704, 3016618143, 3012536737, 2246552, 1721504, 3015910259, 3040153768, 2648727, 3013500228, 3002808128, 1000138054 +48 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.