Cleared Traditional

Tempo Smart Button

K212217 · Eli Lilly and Company · General Hospital

Sep 2022

Decision

427d

Days

Class 2

Risk

About This 510(k) Submission

K212217 is an FDA 510(k) clearance for the Tempo Smart Button, a Injection Data Capture Device (Class II — Special Controls, product code QOG), submitted by Eli Lilly and Company (Indianapolis, US). The FDA issued a Cleared decision on September 16, 2022, 427 days after receiving the submission on July 16, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K212217 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2021
Decision Date	September 16, 2022
Days to Decision	427 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.