Cleared Special

MallyaD injection pen adapter (MallyaD)

K250555 · Biocorp Production · General Hospital

Mar 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K250555 is an FDA 510(k) clearance for the MallyaD injection pen adapter (MallyaD), 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 March 27, 2025, 30 days after receiving the submission on February 25, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K250555 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2025
Decision Date	March 27, 2025
Days to Decision	30 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.