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FDA Product Code

FDA Product Code QOG — Clearance Directory

Device Class
Class II
Assigned Panel
General Hospital
21 CFR Citation
880.5860

510(k) Clearances — 7 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K243901 SmartPilot YpsoMate NS-A2.25 Ypsomed AG 2025-08-28 Traditional PDF ↗
K251500 MallyaG Injection Pen Adapter (MallyaG) Biocorp Production 2025-06-09 Special PDF ↗
K250555 MallyaD injection pen adapter (MallyaD) Biocorp Production 2025-03-27 Special PDF ↗
K241803 INSULCLOCK® v2.0 PRO Insulcloud S.L. 2024-08-22 Traditional PDF ↗
K231820 SoloSmart Injection Pen Adapter (SoloSmart®) Biocorp Production 2024-01-12 Special PDF ↗
K222689 Mallya Injection Pen Adapter (Mallya® for Solostar®) Biocorp Production 2022-12-05 Traditional PDF ↗
K212217 Tempo Smart Button Eli Lilly and Company 2022-09-16 Traditional PDF ↗

Product code QOG · Class II · General Hospital. Data: openFDA.