Cleared Traditional

K262576 - twiist Loop Algorithm

K262576 is an FDA 510(k) clearance for twiist Loop Algorithm, manufactured by Deka Research and Development Corp.. The device is a Class 2 Chemistry device with product code QJI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K262576 · Deka Research and Development Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
80d
Days
Class 2
Risk

K262576 is an FDA 510(k) clearance for the twiist Loop Algorithm. Classified as Interoperable Automated Glycemic Controller (product code QJI), Class II - Special Controls.

Submitted by Deka Research and Development Corp. (Manchester, US). The FDA issued a Cleared decision on October 15, 2026 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1356 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262576

510(k) Number K262576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2026
Decision Date October 15, 2026
Days to Decision 80 days
Submission Type Traditional
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
9d faster than avg
Panel avg: 89d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

QJI Device Classification - Class 2, Special Controls

Product Code QJI Interoperable Automated Glycemic Controller
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1356
Definition An Interoperable Automated Glycemic Controller Is A Device Intended To Automatically Calculate Drug Doses Based On Inputs Such As Glucose And Other Relevant Physiological Parameters, And To Command The Delivery Of Such Drug Doses From A Connected Infusion Pump. Interoperable Automated Glycemic Controllers Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Drug Delivery Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06853990 Completed Interventional Industry-sponsored

Innovative Automated Insulin Delivery System for Type 2 Diabetes

A Single-arm Trial With an Innovative Automated Insulin Delivery System for Type 2 Diabetes ("Twiist-T2D")

307
Patients (actual)
30
Sites
Treatment
Purpose
Open label
Masking
Condition studied Type 2 Diabetes; Insulin Treated Type 2 Diabetes Mellitus
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor Deka Research and Development (industry)
Started 2025-04-14 → Primary completion 2026-02-25 → Completed 2026-05-06
Primary outcome
Change in HbA1c
Secondary outcome
CGM-measured time in and out of range
Study completed - no results published. This trial concluded in 2026 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - QJI Interoperable Automated Glycemic Controller

All 23
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K262576 · twiist Loop Algorithm
Download PDF FDA Summary Deka Research and Dev…