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Embecta Insulin Delivery System

by Embecta Medical I, LLC 510(k)

Active United States

510(k) K234027

Overview

The Embecta Insulin Delivery System is an Alternate Controller Enabled Insulin Infusion Pump, classified as a Class II medical device under regulation number 880.5730. It is designed for the delivery of insulin in the management of diabetes.

The device received FDA 510(k) clearance (K234027) on August 30, 2024, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Embecta Medical I, LLC in Andover, Massachusetts, and is intended for use in clinical settings under the oversight of healthcare professionals.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK234027 Date30 Aug 2024ClearedStatusActive

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

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
QFG
Device Class
Class II
Regulation
21 CFR Part 880.5730
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Embecta Insulin Delivery System used for?

    The Embecta Insulin Delivery System is designed for the delivery of insulin in the management of diabetes, intended for use in clinical settings under the oversight of healthcare professionals as an Alternate Controller Enabled Insulin Infusion Pump.

  • How is the Embecta Insulin Delivery System supplied and is it reusable?

    The device is supplied as a complete insulin infusion pump system intended for use in clinical settings; however, the provided data does not specify whether components are single-use or reusable, so reuse instructions must be obtained from the manufacturer's labeling.

  • What regulatory clearance does the Embecta Insulin Delivery System have?

    The Embecta Insulin Delivery System received FDA 510(k) clearance under submission number K234027 on August 30, 2024, and is classified as a Class II medical device under regulation 880.5730 with product code QFG.