# Tandem Diabetes Care, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 28 (2011–2026): 24 510(k) clearances, 2 De Novo grants and 2 original PMA approvals
- Names in FDA's records: Tandem Diabetes Care, Inc. (27); Tandem Diabetes Care (1)
- Product codes: QFG (10), LZG (7), QJI (6), OYC (1), QJS (1), FPA (1), OUG (1), OZO (1)
- 510(k) review time since 2016: median 87 days, against 116 for FDA's reviews in the same codes and years (8 of 15 faster)
- Predicates its devices cite: 31 (24 its own); citations of its devices by later devices: 33 (24 its own)
- Recalls linked to its devices: 12 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Minimed: 2 (https://510kreport.com/company/medtronic-minimed)
- Companion Medical, Inc.: 1 (https://510kreport.com/company/companion-medical)
- Smiths Medical MD, Inc.: 1 (https://510kreport.com/company/smiths-medical-md)
- Capillary Biomedical, LLC: 1 (https://510kreport.com/company/capillary-biomedical)
- Nipro Diabetes Systems, Inc.: 1 (https://510kreport.com/company/nipro-diabetes-systems)
- Aidera AB: 1 (https://510kreport.com/company/aidera)

## Firms that cite its devices most
- Insulet Corporation: 2 (https://510kreport.com/company/insulet)
- Medtronic Minimed: 2 (https://510kreport.com/company/medtronic-minimed)
- Beta Bionics, Inc.: 2 (https://510kreport.com/company/beta-bionics)
- Tidepool Project: 1 (https://510kreport.com/company/tidepool-project)
- Deka Research and Development: 1 (https://510kreport.com/company/deka-research-and-development)
- Modular Medical, Inc.: 1 (https://510kreport.com/company/modular-medical)

## Its most-cited devices
- K200467: Control-IQ Technology (2020), cited by 4
- DEN180058: t:slim X2 insulin pump with interoperable technology (2019), cited by 3
- K141758: T:Slim Insulin Delivery System (2014), cited by 3
- K232380: t:slim X2 Insulin Pump with Interoperable Technology (2023), cited by 2
- DEN190034: Control-IQ Technology (2019), cited by 2
- K160056: t:slim Insulin Delivery System (2016), cited by 2

## Recent decisions
- K260429: Control-IQ+ technology (Apr 24, 2026)
- K253074: Tandem Mobi insulin pump with interoperable technology (Nov 6, 2025)
- K250792: t:slim X2 insulin pump with interoperable technology (Sep 24, 2025)
- K251854: SteadiSet infusion set (Aug 6, 2025)
- K250798: Control-IQ+ technology (May 21, 2025)
- K243823: Control-IQ+ technology (Feb 24, 2025)
- K241078: Tandem Mobi Insulin Pump with interoperable technology (Jul 26, 2024)
- K240309: Tandem Mobi insulin pump with interoperable technology (Mar 21, 2024)

Source page: https://510kreport.com/company/tandem-diabetes-care