Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860) → QOG — Injection Data Capture Device

# QOG · Injection Data Capture Device

_General Hospital · 21 CFR 880.5860 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG

## Overview

- **Product Code:** QOG
- **Device Name:** Injection Data Capture Device
- **Regulation:** [21 CFR 880.5860](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5860)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## 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](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K243901.md) | SmartPilot YpsoMate NS-A2.25 | Ypsomed AG | Aug 28, 2025 | SESE |
| [K251500](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K251500.md) | MallyaG Injection Pen Adapter (MallyaG) | Biocorp Production | Jun 9, 2025 | SESE |
| [K250555](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K250555.md) | MallyaD injection pen adapter (MallyaD) | Biocorp Production | Mar 27, 2025 | SESE |
| [K241803](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K241803.md) | INSULCLOCK® v2.0 PRO | Insulcloud S.L. | Aug 22, 2024 | SESE |
| [K231820](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K231820.md) | SoloSmart Injection Pen Adapter (SoloSmart®) | Biocorp Production | Jan 12, 2024 | SESE |
| [K222689](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K222689.md) | Mallya Injection Pen Adapter (Mallya® for Solostar®) | Biocorp Production | Dec 5, 2022 | SESE |
| [K212217](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K212217.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG)

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