Cleared Traditional

BlueStar Rx

K193654 · Welldoc, Inc. · Chemistry
Apr 2020
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K193654 is an FDA 510(k) clearance for the BlueStar Rx, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on April 7, 2020, 99 days after receiving the submission on December 30, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K193654 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 2019
Decision Date April 07, 2020
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRZ — Accessories, Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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