Cleared Traditional

Mallya Injection Pen Adapter (Mallya? for Solostar?)

K222689 · Biocorp Production · General Hospital
Dec 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K222689 is an FDA 510(k) clearance for the Mallya Injection Pen Adapter (Mallya? for Solostar?), a Injection Data Capture Device (Class II — Special Controls, product code QOG), submitted by Biocorp Production (Issoire, FR). The FDA issued a Cleared decision on December 5, 2022, 90 days after receiving the submission on September 6, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K222689 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2022
Decision Date December 05, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QOG — Injection Data Capture Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860
Definition An Injection Data Capture Device Is An Electrically-powered/electromechanical Accessory That Interfaces With Reusable Or Disposable Injection Devices For The Purposes Of Interpreting, Recording And Displaying And/or Transmitting Injection Data To A Connected Application Or Software.