What is FDA product code QFG?

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.

General Hospital › TherapeuticAlternate Controller Enabled Insulin Infusion Pump

Ilet Insulin Infusion Kit

Name: iLet Insulin Infusion Kit
Brand: iLet Insulin Infusion Kit

Catalogue number Insulin Only, listed by Beta Bionics, Inc., United States, under Alternate Controller Enabled Insulin Infusion Pump. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

3recalls on this code

Who Else Makes It

All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QFG
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44

Record

Regulatory record for iLet Insulin Infusion Kit
Listed by	Beta Bionics, Inc., United States
FDA product code	QFG
Device type	Alternate Controller Enabled Insulin Infusion Pump
Device class	Class 2
Regulation	21 CFR 880.5730
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2026-03-11

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for iLet Insulin Infusion Kit
Catalogue number	Size	Status
Insulin Only		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tandem Mobi Autosoft XC Kit	Tandem Diabetes Care, Inc.	13
t:slim X2 Insulin Pump with Control-IQ+ Technology	Tandem Diabetes Care, Inc.	12
t:slim X2 Insulin Pump with Control-IQ	Tandem Diabetes Care, Inc.	11
t:slim X2 Insulin Pump with Basal-IQ	Tandem Diabetes Care, Inc.	9
Tandem Mobi	Tandem Diabetes Care, Inc.	5
MiniMed Flex	Medtronic Minimed	4
Tandem Mobi Autosoft 30 Kit	Tandem Diabetes Care, Inc.	4
Omnipod 5 Pod	Insulet Corporation	3
Tandem Mobi TruSteel Kit	Tandem Diabetes Care, Inc.	3
Tandem Mobi Cartridge	Tandem Diabetes Care, Inc.	3
MiniMed Flex Starter Kit	Medtronic, Inc.	2
Omnipod 5 Controller APP	Insulet Corporation	2

Showing 12 of 36. All products under Alternate Controller Enabled Insulin Infusion Pump

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K253976	2026-04-30
K252770	2025-09-29
K231485	2023-06-21
K223846	2023-05-19

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2026-03-12	Class II	Software change control	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 correct	1,080
2025-09-23	Class II	Software design	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	4580
2025-08-13	Class II	Software design	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 use	15 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.