Cleared Special

twiist system (K250930) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250930 · Deka Research & Development Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
5d
Days
Class 2
Risk

K250930 is an FDA 510(k) clearance for the twiist system. Classified as Alternate Controller Enabled Insulin Infusion Pump (product code QFG), Class II - Special Controls.

Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on April 2, 2025 after a review of 5 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5730 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Deka Research & Development Corp. devices

Submission Details

510(k) Number K250930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 88d · This submission: 5d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QFG Alternate Controller Enabled Insulin Infusion Pump
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QFG Alternate Controller Enabled Insulin Infusion Pump

All 26
Devices cleared under the same product code (QFG) and FDA review panel - the closest regulatory comparables to K250930.
iLet ACE Pump
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MiniMed 780G insulin pump
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embecta Insulin Delivery System
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Tandem Mobi Insulin Pump with interoperable technology
K241078 · Tandem Diabetes Care, Inc. · Jul 2024
DEKA ACE Pump System
K241178 · Deka Research and Development · May 2024