Cleared Traditional

Vivo 45 LS

K232365 · Oconnell Regulatory Consultants, Inc. · Anesthesiology
Dec 2025
Decision
865d
Days
Class 2
Risk

About This 510(k) Submission

K232365 is an FDA 510(k) clearance for the Vivo 45 LS, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Oconnell Regulatory Consultants, Inc. (Stoneham, US). The FDA issued a Cleared decision on December 19, 2025, 865 days after receiving the submission on August 7, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K232365 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2023
Decision Date December 19, 2025
Days to Decision 865 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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