Injection Data Capture Device
General Hospital · 21 CFR 880.5860
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.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
Ypsomed Ag
SOLOTHURN, SOLOTHURN, CH
Abbott Diabetes Care Inc.
ALAMEDA, CA, US
Eli Lilly And Company, Pharmaceutical Delivery Systems
Indianapolis, IN, US
Rr Donnelley-supply Chain Solutions
Plover, WI, US
Bigfoot Biomedical, Inc.
Milpitas, CA, US
Ypsomed Ag
BURGDORF Bern, CH
Flextronics International Gmbh
ALTHOFEN Karnten, AT
510(k) clearances
7 clearances for this product code
- Ypsomed AGAug 28, 2025
K243901 · SmartPilot YpsoMate NS-A2.25
- Biocorp ProductionJun 9, 2025
K251500 · MallyaG Injection Pen Adapter (MallyaG)
- Biocorp ProductionMar 27, 2025
K250555 · MallyaD injection pen adapter (MallyaD)
- Insulcloud S.L.Aug 22, 2024
K241803 · INSULCLOCK® v2.0 PRO
- Biocorp ProductionJan 12, 2024
K231820 · SoloSmart Injection Pen Adapter (SoloSmart®)
- Biocorp ProductionDec 5, 2022
K222689 · Mallya Injection Pen Adapter (Mallya® for Solostar®)
- Eli Lilly and CompanySep 16, 2022
K212217 · Tempo Smart Button