Cleared Traditional

K251152 - DBLG2 (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence.

K251152 · Diabeloop · Chemistry device
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Dec 2025
Decision
249d
Days
Class 2
Risk

K251152 is an FDA 510(k) clearance for the DBLG2. Classified as Interoperable Automated Glycemic Controller (product code QJI), Class II - Special Controls.

Submitted by Diabeloop (Grenoble, FR). The FDA issued a Cleared decision on December 19, 2025 after a review of 249 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diabeloop devices

Submission Details

510(k) Number K251152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2025
Decision Date December 19, 2025
Days to Decision 249 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 88d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. PCCP authorized - AI/SaMD pathway.

Device Classification

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
NCT02987556 Completed Interventional

Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)

Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.

71
Patients (actual)
12
Sites
Treatment
Purpose
Open label
Masking
Condition studied Closed Loop; Diabetes Mellitus, Type 1
Study design Crossover
Eligibility All sexes · 18 Years+
Sponsor Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Started 2017-03-30 → Primary completion 2018-08-28
Primary outcome
Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
Secondary outcome
Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks
Study completed - no results published. This trial concluded in 2018 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 19
Devices cleared under the same product code (QJI) and FDA review panel - the closest regulatory comparables to K251152.
Control-IQ+ technology
K260429 · Tandem Diabetes Care, Inc. · Apr 2026
SmartGuard Technology
K253701 · Medtronic Minimed · Feb 2026
SmartGuard technology
K253585 · Medtronic Minimed, Inc. · Jan 2026
Omnipod 5 algorithm
K251779 · Insulet Corporation · Dec 2025
SmartGuard technology
K251217 · Medtronic Minimed, Inc. · Aug 2025
Control-IQ+ technology
K250798 · Tandem Diabetes Care, Inc. · May 2025