Data / Medical devices / United States / Beta Bionics, Inc.

Beta Bionics, Inc.: FDA-registered device maker in Irvine, CA, United States, 8 510(k) clearances

Name: Beta Bionics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Beta Bionics, Inc. is registered with the FDA (registration 3019004087) in Irvine, CA, United States. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated October 21, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3019004087
Address: 11 Hughes, Irvine, CA, United States, 92618
Owner or operator: Beta Bionics, Inc. (10088071)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: May 22, 2023
Registered through: 2027
Brand names listed: Beta Bionics Mobile Application, Bionic Circle App, Android, Bionic Circle App, iOS, Clinical Data and Visualization Application, Mint, Mint ACE Pump, Mint Cartridge, Mint Controller and more

Devices it lists

Device	Product code	Class	Role	Source
Alternate Controller Enabled Insulin Infusion Pump	QFG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Continuous Glucose Monitor Retrospective Data Analysis Software	PHV	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Insulin Pump Secondary Display	PKU	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Interoperable Automated Glycemic Controller	QJI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Piston	FMF	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 21, 2026	K263422	Mint ACE Pump	QFG	Substantially Equivalent	Beta Bionics, Inc.	accessdata.fda.gov
May 19, 2023	K223846	iLet® ACE Pump	QFG	Substantially Equivalent	Beta Bionics, Inc.	accessdata.fda.gov
May 19, 2023	K220916	iLet® Dosing Decision Software	QJI	Substantially Equivalent	Beta Bionics, Inc.	accessdata.fda.gov
March 5, 2018	K173879	MiniMed Mio Advance infusion set	FPA	Substantially Equivalent	Unomedical A/S	accessdata.fda.gov
May 13, 2011	K110771	BD SINGLE USE, HYPODERMIC SYRINGE	FMF	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
June 30, 2004	K041545	CONTACT DETACH	FPA	Substantially Equivalent	Unomedical A/S	accessdata.fda.gov
October 9, 2003	K032854	UNOMEDICAL MONICA INFUSION SET	FPA	Substantially Equivalent	Unomedical A/S	accessdata.fda.gov
July 19, 2002	K021475	BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET	FMI	Substantially Equivalent	Bd	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 12, 2026	98475	Class II	Ongoing	iLet Bionic Pancreas, REF: BB1001	insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacemen	accessdata.fda.gov
September 23, 2025	98517	Class II	Ongoing	iLet Bionic Pancreas, REF: BB1001	The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is una	accessdata.fda.gov
August 13, 2025	98528	Class II	Ongoing	iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software	it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those screens when those icons on the status bar are pressed, allowing unauthorized access while the device	accessdata.fda.gov

Compare with other makers

Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.