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Beta Bionics, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 11 Hughes, Irvine, CA, 92618
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 855-745-3800
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3019004087
DUNS Number: 835742136

Catalogue (33)

Device	Model / Reference	Registries	Class	Status
iLet Bionic Pancreas	Insulin Only	FDA UDI	Class II	Active
iLet Starter Kit - Contact Detach	Insulin Only	FDA UDI	Class II	Active
iLet Insulin Infusion Kit – Inset™ (23", 6mm) 10-Pack	Insulin Only	FDA UDI	Class II	Active
iLet Insulin Infusion Kit – Inset™ (32") 10-Pack	Insulin Only	FDA UDI	Class II	Active
iLet Bionic Pancreas	Insulin Only	FDA UDI	Class II	Active
iLet Insulin Infusion Kit - Inset (23”, 6mm) 15-Pack (Pharmacy Kit)	Insulin Only	FDA UDI	Class II	Active
Bionic Circle App, Android	BOM000083	FDA UDI	Class II	Active
iLet Connect Adapter 15-Pack (BB3052)	Insulin Only	FDA UDI	Class II	Active
iLet Bionic Pancreas	Insulin Only	FDA UDI	Class II	Active
iLet Inset Insulin Infusion Set (32”, 6mm)	Insulin Only	FDA UDI	Class II	Active
iLet Bionic Pancreas	Insulin Only	FDA UDI	Class II	Active
iLet Cartridge Kit 15-Pack (1.6mL/160 Units)	Insulin Only	FDA UDI	Class II	Active
iLet Inset Insulin Infusion Set (23”, 6mm)	Insulin Only	FDA UDI	Class II	Active
iLet Insulin Infusion Kit – Contact Detach™ (23"", 6mm) - 20-Pack	Insulin Only	FDA UDI	Class II	Active
iLet Contact Detach Insulin Infusion Set (23”, 6mm)	Insulin Only	FDA UDI	Class II	Active
Bionic Circle App, iOS	BOM000082	FDA UDI	Class II	Active
iLet Connect Adapter	Insulin Only	FDA UDI	Class II	Active
iLet Cartridge Kit	Insulin Only	FDA UDI	Class II	Active
iLet Inset Insulin Infusion Set (23”, 6mm)	Insulin Only	FDA UDI	Class II	Active
iLet Insulin Infusion Kit – Contact Detach (23”, 6mm) 15-Pack (Pharmacy Kit)	Insulin Only	FDA UDI	Class II	Active
iLet Contact Detach Insulin Infusion Set (23”, 6mm)	Insulin Only	FDA UDI	Class II	Active
iLet Starter Kit - Inset 23"	Insulin Only	FDA UDI	Class II	Active
iLet Bionic Pancreas	Insulin Only	FDA UDI	Class II	Active
iLet Insulin Infusion Kit - Inset (32”, 6mm) 15-Pack (Pharmacy Kit)	Insulin Only	FDA UDI	Class II	Active
iLet Bionic Pancreas	Insulin Only	FDA UDI	Class II	Active
iLet Starter Kit - Inset 32"	Insulin Only	FDA UDI	Class II	Active
iLet Inset Insulin Infusion Set (32”, 6mm)	Insulin Only	FDA UDI	Class II	Active
iLet ACE Pump	K253976	FDA 510(k)	Class II	Active
iLet® ACE Pump	K231485	FDA 510(k)	Class II	Active
iLet® Dosing Decision Software	K232224	FDA 510(k)	Class II	Active
iLet® Dosing Decision Software	K220916	FDA 510(k)	Class II	Active
iLet® ACE Pump	K223846	FDA 510(k)	Class II	Active
iLet ACE Pump	K252770	FDA 510(k)	Class II	Active

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 12, 2026	Z-1996-2026	—	open, classified	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 replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
Aug 13, 2025	Z-1809-2026	—	open, classified	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 is in Limited Access Mode. A Health Risk associated with Limited access mode includes severe hypoglycemia due to unauthorized access to the iLet if someone were to make unauthorized meal announcements or stopped insulin delivery.