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FDA 510(k)

Arterial Pressure Monitoring Set/Tray

K-Number: K254278 · 2026-03-25

ApplicantSpectrum Vascular
Decision Date2026-03-25
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arterial Pressure Monitoring Set/Tray is a medical device manufactured by Spectrum Vascular. It received FDA 510(k) clearance on 2026-03-25 under approval number K254278. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arterial Pressure Monitoring Set/Tray?

Arterial Pressure Monitoring Set/Tray is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Spectrum Vascular. The 510(k) number is K254278.

When was Arterial Pressure Monitoring Set/Tray approved by the FDA?

Arterial Pressure Monitoring Set/Tray received FDA 510(k) clearance on 2026-03-25, under approval number K254278.

What company makes Arterial Pressure Monitoring Set/Tray?

Arterial Pressure Monitoring Set/Tray is manufactured by Spectrum Vascular.

What is the FDA product code for Arterial Pressure Monitoring Set/Tray?

The FDA product code for Arterial Pressure Monitoring Set/Tray is DQO.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT06466161 Conical Forearm and Cylindrical Upper Arm Non-Invasive Blood Pressure (NIBP) Measurements in Pregnant Patients RECRUITING NCT05673408 NIBP Validation Study RECRUITING NCT07592481 Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

Other Devices by Spectrum Vascular

K241115SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous Catheter K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology K250724Intraosseous Infusion Needles

Related Devices (Code: DQO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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