Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016540876

FEI Number

3016540876

Entity Name

TANDEM DIABETES CARE, INC.

City/State/Country

San Diego, CA, US

Establishment Address

6495 Marindustry Place, San Diego, CA 92121, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tandem Diabetes Care, Inc. (Owner Number: 10039506)

Owner / Operator Contact Address

12400 High Bluff Drive, San Diego, CA 92130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232382

PMA Number

N/A

All Registered Proprietary Names

t:slim X2 with Control-IQ technology t:slim X2 t:slim pump insulin delivery system Tandem Mobi System Tandem Mobi System t:slim X2 with Basal-IQ technology Tandem Mobi System T:slim X2 Insulin Pump Control-IQ Technology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2022-04-14
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2020-11-23
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2012-01-16
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2024-08-19
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2023-08-02
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2019-11-13
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2019-12-16
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2020-11-23
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2024-08-19
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2023-12-01
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2023-12-01

Official Correspondent

Mark Tarby

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tandem Diabetes Care, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027327302	TANDEM DIABETES CARE, INC.	Irvine, CA, US
3026266833	Tandem Diabetes Care Europe B.V.	Schiphol Noord-Holland, NL
3013756811	Tandem Diabetes Care, INC.	San Diego, CA, US
3032746481	TANDEM DIABETES CARE, INC.	San Diego, CA, US
3007981285	TANDEM DIABETES CARE, INC.	San Diego, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082590	Lifescan, Inc.	SYMPHONY METER REMOTE	2008-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2013	Animas Corporation	2	IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Z-0010-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 712
Z-0011-05	Medtronic MiniMed	2	Medtronic MiniMed Paradigm Model 512

Similar Registrations

Registration Number	Establishment Name	Location
3014197758	FEDEX SUPPLY CHAIN, INC.	Olive Branch, MS, US
3007981285	TANDEM DIABETES CARE, INC.	San Diego, CA, US
2032227	MEDTRONIC MINIMED	NORTHRIDGE, CA, US
3019004087	BETA BIONICS, INC.	Irvine, CA, US
3016798778	MILLYARD ADVANCED MEDICAL PRODUCTS LLC	Manchester, NH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016540876. Last updated year: 2026. Please use registration number 3016540876 when referencing this establishment in official correspondence.