Chrysalis Intelligence · Sponsors · Beta Bionics, Inc.

Beta Bionics, Inc.

Concord, MA, US · 8 510(k) clearances · 2 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

8

2023-05-19 → 2026-09-11

Last 12 months

3

Product codes

2

Most recent

2026-09-11

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QFG	Alternate Controller Enabled Insulin Infusion Pump	Class II	Clinical Chemistry	5	2026-09-11
QJI	Interoperable Automated Glycemic Controller	Class II	Clinical Chemistry	3	2026-09-11

Safety

Recalls (2)

Class I (serious)

0

Risk of injury / death

Total recalls

2

Currently ongoing

2

Most recent

2026-03-12

Date	Severity	Status	Recall #	Product	Code	Reason
2026-03-12	Class II	Ongoing	Z-1996-2026	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 t…
2025-08-13	Class II	Ongoing	Z-1809-2026	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 cer…

Filings

All 510(k) clearances (8)

Date	K-number	Device	Code	Class	Specialty
2026-09-11	K262763	iLet Dosing Decision Software	QJI	Class II	Clinical Chemistry
2026-09-11	K260001	Mint ACE Pump	QFG	Class II	Clinical Chemistry
2026-04-30	K253976	iLet ACE Pump	QFG	Class II	Clinical Chemistry
2025-09-29	K252770	iLet ACE Pump	QFG	Class II	Clinical Chemistry
2023-09-22	K232224	iLet® Dosing Decision Software	QJI	Class II	Clinical Chemistry
2023-06-21	K231485	iLet® ACE Pump	QFG	Class II	Clinical Chemistry
2023-05-19	K223846	iLet® ACE Pump	QFG	Class II	Clinical Chemistry
2023-05-19	K220916	iLet® Dosing Decision Software	QJI	Class II	Clinical Chemistry