T:Slim (TM) Insulin Delivery System
FDA 510(k) K111210 · Tandem Diabetes Care, Inc.
510(k) numberK111210
Submission
- Device name
- T:Slim (TM) Insulin Delivery System
- Applicant
- Tandem Diabetes Care, Inc.
San Diego, CA, US - Received
- April 29, 2011
- Decision date
- November 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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|---|---|---|---|
| K262153 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/02/2026SE |
| K253534 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical | 04/08/2026SE |
| K240158 | Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/04/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | Medtronic Minimed | 07/02/2024SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | Insulet Corporation | 04/24/2023SE |
| K210714 | Extended ReservoirLZG · Traditional | Medtronic Minimed, Inc. | 04/06/2022SE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional | Insulet Corporation | 08/13/2021SE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 10/21/2019SE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 06/01/2018SE |
More from Insulet Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K260429 | Control-IQ+ technologyQJI · Traditional | 04/24/2026SE |
| K253074 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | 11/06/2025SE |
| K250792 | t:slim X2 insulin pump with interoperable technologyQFG · Traditional | 09/24/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | 08/06/2025SE |
| K250798 | Control-IQ+ technologyQJI · Traditional | 05/21/2025SE |
| K243823 | Control-IQ+ technologyQJI · Traditional | 02/24/2025SE |
| K241078 | Tandem Mobi Insulin Pump with interoperable technologyQFG · Traditional | 07/26/2024SE |
| K240309 | Tandem Mobi insulin pump with interoperable technologyQFG · Traditional | 03/21/2024SE |
| K232382 | Control-IQ TechnologyQJI · Traditional | 11/03/2023SE |
| K232380 | t:slim X2 Insulin Pump with Interoperable TechnologyQFG · Traditional | 11/03/2023SE |
Questions and answers
When was T:Slim (TM) Insulin Delivery System cleared by the FDA?
T:Slim (TM) Insulin Delivery System (K111210) received a 510(k) decision of Substantially Equivalent on November 9, 2011, 194 days after the submission was received.
What is the product code of K111210?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.