Cleared Special

twiist system

K250930 · Deka Research & Development Corp. · Chemistry

Apr 2025

Decision

Days

Class 2

Risk

About This 510(k) Submission

K250930 is an FDA 510(k) clearance for the twiist system, a Alternate Controller Enabled Insulin Infusion Pump (Class II — Special Controls, product code QFG), submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on April 2, 2025, 5 days after receiving the submission on March 28, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5730.

Submission Details

510(k) Number	K250930 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2025
Decision Date	April 02, 2025
Days to Decision	5 days
Submission Type	Special
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.