Cleared Special

SoloSmart Injection Pen Adapter (SoloSmart?)

K231820 · Biocorp Production · General Hospital

Jan 2024

Decision

205d

Days

Class 2

Risk

About This 510(k) Submission

K231820 is an FDA 510(k) clearance for the SoloSmart Injection Pen Adapter (SoloSmart?), 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 January 12, 2024, 205 days after receiving the submission on June 21, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K231820 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2023
Decision Date	January 12, 2024
Days to Decision	205 days
Submission Type	Special
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.