QOG · Injection Data Capture Device
General Hospital · 21 CFR 880.5860 · Class 2
Overview
| Product Code | QOG |
|---|---|
| Device Name | Injection Data Capture Device |
| Regulation | 21 CFR 880.5860 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | Aug 28, 2025 | SESE |
| K251500 | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | Jun 9, 2025 | SESE |
| K250555 | MallyaD injection pen adapter (MallyaD) | Biocorp Production | Mar 27, 2025 | SESE |
| K241803 | INSULCLOCK® v2.0 PRO | Insulcloud S.L. | Aug 22, 2024 | SESE |
| K231820 | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | Jan 12, 2024 | SESE |
| K222689 | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | Dec 5, 2022 | SESE |
| K212217 | Tempo Smart Button | Eli Lilly and Company | Sep 16, 2022 | SESE |
Top Applicants
- Biocorp Production — 4 clearances
- Eli Lilly and Company — 1 clearance
- Insulcloud S.L. — 1 clearance
- Ypsomed AG — 1 clearance
