Skip to content

MallyaD Injection Pen Adapter

by Biocorp Production France 510(k)

510(k) K250555 Product code QOG

Overview

The MallyaD injection pen adapter is an injection data capture device designed to attach to the button of compatible Novo Nordisk PDS290 injection pens. It functions as a smart sensor that captures dosing information by sensing the rotation of the pen's dosing mechanism during dose setting.

The device transmits the dialed dose increment, date, and time of injection via Bluetooth Low Energy to a mobile application. This device has received FDA 510(k) clearance.

Summary written by AI from registry data, 27 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK250555 Date27 Mar 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

Full name
MallyaD injection pen adapter (MallyaD)
510(k) Number
FDA Product Code
QOG
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Biocorp Production

See all devices from Biocorp Production →

Questions

  • What is the primary function of the MallyaD injection pen adapter?

    The MallyaD is an injection data capture device designed to attach to the button of compatible Novo Nordisk PDS290 injection pens. It acts as a smart sensor that monitors the rotation of the pen's dosing mechanism to record the specific dose, date, and time of each injection.

  • How does the MallyaD device share captured injection data?

    Once the device captures the dosing information, it transmits the data via Bluetooth Low Energy technology to a connected mobile application. This allows for the digital tracking of injection history.

  • Is the MallyaD injection pen adapter cleared for use?

    Yes, the MallyaD injection pen adapter has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K250555 24 fields · synced 6 Oct 2026