Cleared Traditional

INSULCLOCK? v2.0 PRO

K241803 · Insulcloud S.L. · General Hospital

Aug 2024

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K241803 is an FDA 510(k) clearance for the INSULCLOCK? v2.0 PRO, a Injection Data Capture Device (Class II — Special Controls, product code QOG), submitted by Insulcloud S.L. (Bibao, ES). The FDA issued a Cleared decision on August 22, 2024, 62 days after receiving the submission on June 21, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K241803 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2024
Decision Date	August 22, 2024
Days to Decision	62 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.