TANDEM DIABETES CARE, INC.

FDA Device Registration & Listing · San Diego, CA, US · Registration 3032746481

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3032746481
FEI Number
3032746481
Entity Name
TANDEM DIABETES CARE, INC.
City/State/Country
San Diego, CA, US
Establishment Address
5995 Pacific Center Blvd Ste 104, 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
N
Expiration Date (Year)
2026
510(k) Number
K223213
PMA Number
N/A

All Registered Proprietary Names

Tandem Mobi Adhesive Sleeve Tandem Mobi System Tandem Mobi System T:slim X2 Insulin Pump Tandem Mobi System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2024-08-19
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 2022-04-14
QFG Alternate Controller Enabled Insulin Infusion Pump Clinical Chemistry Class 2 880.5730 2023-12-01
QFG Alternate Controller Enabled Insulin Infusion Pump Clinical Chemistry Class 2 880.5730 2023-08-02

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
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
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032746481. Last updated year: 2026. Please use registration number 3032746481 when referencing this establishment in official correspondence.
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