Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

twiist Automated Insulin Delivery (AID) System

K-Number: K261672 · 2026-06-17

ApplicantDeka Research and Development
Decision Date2026-06-17
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

twiist Automated Insulin Delivery (AID) System is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K261672. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the twiist Automated Insulin Delivery (AID) System?

twiist Automated Insulin Delivery (AID) System is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Deka Research and Development. The 510(k) number is K261672.

When did twiist Automated Insulin Delivery (AID) System receive FDA 510(k) clearance?

twiist Automated Insulin Delivery (AID) System received FDA 510(k) clearance on 2026-06-17, under 510(k) number K261672.

Who is the listed applicant for twiist Automated Insulin Delivery (AID) System?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for twiist Automated Insulin Delivery (AID) System?

The FDA product code for twiist Automated Insulin Delivery (AID) System is QFG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06853990Innovative Automated Insulin Delivery System for Type 2 DiabetesCOMPLETEDNCT05866900The Impact of Daily Carbohydrate Intake on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using an Advanced Hybrid Closed-loop SystemCOMPLETEDNCT06024928Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 DiabetesCOMPLETEDNCT06883344Automated Insulin for Management of Intrapartum GlycemiaRECRUITINGNCT07039617A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)RECRUITINGNCT07212179Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin DeliveryCOMPLETED

Other records listing Deka Research and Development as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261530iiSure Infusion SetK243841Sparta Infusion Set for InsulinK241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionK242693DEKA Infusion System, DEKA Administration SetK240920HemoCare Bicarbonate Concentrate Set (BCS)K233557HemoCare Hemodialysis System

View all 14 devices →

Related Devices (Code: QFG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.K252770iLet ACE PumpBeta Bionics, Inc.K250792t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑