Cleared Traditional

K213536 - DEKA ACE Pump System (FDA 510(k) Clearance)

K213536 · Deka Research and Development · Chemistry device

Jul 2023

Decision

627d

Days

Class 2

Risk

K213536 is an FDA 510(k) clearance for the DEKA ACE Pump System. This device is classified as a Alternate Controller Enabled Insulin Infusion Pump (Class II - Special Controls, product code QFG).

Submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on July 25, 2023, 627 days after receiving the submission on November 5, 2021.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5730. An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery..

Submission Details

510(k) Number	K213536 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 2021
Decision Date	July 25, 2023
Days to Decision	627 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QFG - Alternate Controller Enabled Insulin Infusion Pump
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 880.5730
Definition	An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery.