Cleared Traditional

ReddyPort Elbow

K231064 · Smd Manufacturing, LLC · Anesthesiology
Jul 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K231064 is an FDA 510(k) clearance for the ReddyPort Elbow, a Ventilator, Continuous, Non-life-supporting (Class II — Special Controls, product code MNS), submitted by Smd Manufacturing, LLC (Salt Lake City, US). The FDA issued a Cleared decision on July 13, 2023, 90 days after receiving the submission on April 14, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K231064 FDA.gov
FDA Decision Cleared SESE
Date Received April 14, 2023
Decision Date July 13, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNS — Ventilator, Continuous, Non-life-supporting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895