Cleared Special

K252770 - iLet ACE Pump (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway.

K252770 · Beta Bionics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
27d
Days
Class 2
Risk

K252770 is an FDA 510(k) clearance for the iLet ACE Pump. Classified as Alternate Controller Enabled Insulin Infusion Pump (product code QFG), Class II - Special Controls.

Submitted by Beta Bionics, Inc. (Concord, US). The FDA issued a Cleared decision on September 29, 2025 after a review of 27 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 Beta Bionics, Inc. devices

Submission Details

510(k) Number K252770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2025
Decision Date September 29, 2025
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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. 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
NCT04200313 Completed Interventional

The Insulin-Only Bionic Pancreas Pivotal Trial

The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children With Type 1 Diabetes

440
Patients (actual)
16
Sites
Treatment
Purpose
Open label
Masking
Condition studied Diabetes Mellitus; Type 1 Diabetes; Diabetes Mellitus, Type 1
Study design Parallel
Eligibility All sexes · 6 Years+
Principal investigator R. Paul Wadwa, MD
Sponsor Jaeb Center for Health Research
Started 2020-03-31 → Primary completion 2021-10-30 → Completed 2022-01-14
Primary outcome
HbA1c
Secondary outcome
Non-inferiority for CGM-measured Time <54 mg/dL (Key Secondary Endpoint)
View full study on ClinicalTrials.gov

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 K252770.
iLet ACE Pump
K253976 · Beta Bionics, Inc. · Apr 2026
MiniMed Flex pump
K253743 · Medtronic Minimed, Inc. · Mar 2026
MiniMed 780G Insulin Pump (MMT-1884)
K253470 · Medtronic Minimed, Inc. · Jan 2026
Tandem Mobi insulin pump with interoperable technology
K253074 · Tandem Diabetes Care, Inc. · Nov 2025
t:slim X2 insulin pump with interoperable technology
K250792 · Tandem Diabetes Care, Inc. · Sep 2025
MiniMed 780G insulin pump
K251032 · Medtronic Minimed, Inc. · Jul 2025