Cleared Traditional

VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)

K251904 · Remington Medical, Inc. · Cardiovascular

Nov 2025

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K251904 is an FDA 510(k) clearance for the VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01), a Flowmeter, Blood, Cardiovascular (Class II — Special Controls, product code DPW), submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 20, 2025, 153 days after receiving the submission on June 20, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2100.

Submission Details

510(k) Number	K251904 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2025
Decision Date	November 20, 2025
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF