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.

Tandem T: slimTruSteel Kit · Interoperable Automated Glycemic Controller → Clinical Chemistry

1manufacturer

1catalogue number

6510(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 Tandem t:slimTruSteel Kit
Listed by	Tandem Diabetes Care, Inc., United States
FDA product code	QJI
Device type	Interoperable Automated Glycemic Controller
Device class	Class 2
Regulation	21 CFR 862.1356
Establishment	Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K232380
Record published	2025-12-12

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 Tandem t:slimTruSteel Kit
Catalogue number	Size	Status
1018594		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
twiist	Sequel MED Tech, LLC	8
iLet Bionic Pancreas	Beta Bionics, Inc.	6
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
iLet Starter Kit – Inset 32″	Beta Bionics, Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260429	2026-04-24
K250798	2025-05-21
K243823	2025-02-24
K232382	2023-11-03
K200467	2020-06-16
DEN190034	2019-12-13

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Tandem t:slimTruSteel Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Tandem Diabetes Care, Inc.	510(k) number	2026-01-30	Class II	Process change control	The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confir	1,380 units
Tandem Diabetes Care, Inc.	510(k) number	2025-07-03	Class II	Software design	an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.	19
Tandem Diabetes Care, Inc.	510(k) number	2025-02-27	Class I	Software Design Change	A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is	63 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.

Tandem T: slimTruSteel Kit