Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013756811

FEI Number

3013756811

Entity Name

Tandem Diabetes Care, INC.

City/State/Country

San Diego, CA, US

Establishment Address

10151 Barnes Canyon Road, 10151 Barnes Canyon Road, San Diego, CA 92121, US

Establishment Type(s)

Remanufacture Medical Device,Repack or Relabel Medical Device,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

K232380

PMA Number

N/A

All Registered Proprietary Names

Tandem Mobi System t:slim X2 t:slim insulin delivery system t:slim X2 with Basal-IQ technology t:slim X2 t:slim X2 with Basal-IQ t:slim X2 Insulin Pump t:slim X2 Insulin Pump with Basal-IQ t:slim X2 with Control-IQ technology Tandem Mobi Adhesive Sleeve t:slim Insulin Delivery System Control-IQ Technology t:slim X2 t:slim pump insulin delivery system t:slim X2 with Basal-IQ Technology Tandem Mobi System t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM t:slim G4 System Tandem Mobi System T:slim X2 Insulin Pump

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	2024-08-19
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2017-04-26
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2014-05-29
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2020-11-23
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
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2020-11-23
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	2022-04-14
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2016-03-02
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2023-12-01
LZG	Pump, Infusion, Insulin	General Hospital	Class 2	880.5725	2012-01-16
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
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2023-08-02
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	Class 2	862.1356	2019-12-16
OYC	Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	Unknown	Class 3	N/A	2015-09-09
MDS	Sensor, Glucose, Invasive	Unknown	Class 3	N/A	2015-09-09
PQF	Sensor, Glucose, Invasive, Non-Adjunctive	Unknown	Class 3	N/A	2015-09-09
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	Class 2	880.5730	2019-11-13
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

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
3032746481	TANDEM DIABETES CARE, INC.	San Diego, CA, US
3007981285	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
Z-0002-2025	Medtronic MiniMed, Inc.	3	MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868 MiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862

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 3013756811. Last updated year: 2026. Please use registration number 3013756811 when referencing this establishment in official correspondence.