Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007981285

FEI Number

3007981285

Entity Name

TANDEM DIABETES CARE, INC.

City/State/Country

San Diego, CA, US

Establishment Address

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

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

Tandem Mobi System Alternate Controller Enabled Insulin Infusion Pump t:slim X2 Tandem Mobi System Tandem Mobi Adhesive Sleeve T:slim X2 Insulin Pump t:slim X2 t:slim X2 with Basal-IQ t:slim X2 Insulin Pump t:slim X2 Insulin Pump with Basal-IQ t:flex Insulin Delivery System t:slim Insulin Delivery System t:slim insulin delivery system t:Connect mobile app Sugarmate Platform; Sugarmate, Alexa Skill Application; Sugarmate, Android Mobile Application; Sugarmate, iOS Mobile App t:slim X2 with Basal-IQ technology t:slim X2 with Basal-IQ Technology 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	2023-08-02
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2025-12-11
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2017-04-26
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2024-08-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-12-01
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2023-12-01
PQF	Sensor, Glucose, Invasive, Non-Adjunctive	Unknown	Class 3	N/A	2018-07-27
OZO	Automated Insulin Dosing , Threshold Suspend	Unknown	Class 3	N/A	2018-07-27
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2016-03-02
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2016-03-02
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2014-05-29
PJT	Continuous Glucose Monitor Secondary Display	Clinical Chemistry	Class 2	862.1350	2020-11-23
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
QJS	Interoperable Automated Glycemic Controller, Insulin Suspend	Clinical Chemistry	Class 2	862.1356	2020-11-23
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2020-11-23
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
3016540876	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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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
Z-0001-2025	Medtronic MiniMed, Inc.	3	MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007981285. Last updated year: 2026. Please use registration number 3007981285 when referencing this establishment in official correspondence.