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510(k) K212217

Tempo Smart Button by Eli Lilly and Company — Product Code QOG

K212217 is an FDA 510(k) premarket notification submitted by Eli Lilly and Company for the device "Tempo Smart Button". The FDA issued a decision of Substantially Equivalent on September 16, 2022. The device falls under product code QOG (Injection Data Capture Device), a Class II device regulated under 21 CFR 880.5860. Eli Lilly and Company has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2022
Date Received
July 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injection Data Capture Device
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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.

Other clearances by Eli Lilly and Company

  • K160949 — Go Dose System (December 22, 2016)
  • K142518 — HumaPen Luxura (June 5, 2015)
  • K100988 — HUMAPEN LUXURA HD (August 17, 2010)
  • K063151 — HUMAPEN LUXURA HD (January 9, 2007)
  • K053563 — HUMAPEN MEMOIR (April 7, 2006)
  • K982842 — HUMAPEN AND HUMAPEN ERGO (September 25, 1998)

Other clearances for product code QOG

  • K243901 — SmartPilot YpsoMate NS-A2.25 (August 28, 2025)
  • K251500 — MallyaG Injection Pen Adapter (MallyaG) (June 9, 2025)
  • K250555 — MallyaD injection pen adapter (MallyaD) (March 27, 2025)
  • K241803 — INSULCLOCK® v2.0 PRO (August 22, 2024)
  • K231820 — SoloSmart Injection Pen Adapter (SoloSmart®) (January 12, 2024)
  • K222689 — Mallya Injection Pen Adapter (Mallya® for Solostar®) (December 5, 2022)

FDA data resources