What is FDA product code QJI?

An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

Ilet Bionic Pancreas · Interoperable Automated Glycemic Controller → Clinical Chemistry

Name: iLet Bionic Pancreas
Brand: iLet Bionic Pancreas

1manufacturer

6catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

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

Record

Regulatory record for iLet Bionic Pancreas
Listed by	Beta Bionics, Inc., United States
FDA product code	QJI
Device type	Interoperable Automated Glycemic Controller
Device class	Class 2
Regulation	21 CFR 862.1356
Establishment	Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2024-11-06
Record revised	2026-03-20 (version 3)

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for iLet Bionic Pancreas
Catalogue number	Size	Status
Insulin Only		In distribution
Insulin Only		In distribution
Insulin Only		In distribution
Insulin Only		In distribution
Insulin Only		In distribution
Insulin Only		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
twiist	Sequel MED Tech, LLC	8
Tandem t:slim Autosoft 30 Kit	Tandem Diabetes Care, Inc.	4
Tandem t:slim Autosoft XC Kit	Tandem Diabetes Care, Inc.	2
iLet Starter Kit – Inset 23″	Beta Bionics, Inc.	1
iLet Starter Kit	Beta Bionics, Inc.	1
t:slim X2 Insulin Pump with Control-IQ	Tandem Diabetes Care, Inc.	1
iLet Starter Kit – Contact Detach	Beta Bionics, Inc.	1
Tandem t:slimTruSteel Kit	Tandem Diabetes Care, Inc.	1
iLet Starter Kit – Inset 32″	Beta Bionics, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232224	2023-09-22
K220916	2023-05-19

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.

Ilet Bionic Pancreas