LZG — Pump, Infusion, Insulin Class II
FDA product code LZG covers "Pump, Infusion, Insulin", a Class II medical device regulated under 21 CFR 880.5725. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LZG
- Device Class
- Class II
- Regulation Number
- 880.5725
- Submission Type
- Review Panel
- CH
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253534 | modular medical | Pivot Insulin Delivery System | April 8, 2026 |
| K240158 | modular medical | Modular Medical MODD1 Insulin Delivery System | September 4, 2024 |
| K241622 | medtronic minimed | Extended Reservoir; MiniMed Reservoir | July 2, 2024 |
| K223372 | insulet corporation | Omnipod GO Insulin Delivery Device | April 24, 2023 |
| K210714 | medtronic minimed | Extended Reservoir | April 6, 2022 |
| K211575 | insulet corporation | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | August 13, 2021 |
| K192659 | insulet corporation | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | October 21, 2019 |
| K182630 | insulet corporation | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | January 8, 2019 |
| K180045 | insulet corporation | Omnipod DASH Insulin Management System | June 1, 2018 |
| K162296 | insulet corporation | OmniPod Insulin Management System | April 18, 2017 |
| K162080 | tandem diabetes care | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Up | October 25, 2016 |
| K160056 | tandem diabetes care | t:slim Insulin Delivery System | July 25, 2016 |
| K160482 | tandem diabetes care | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Up | July 13, 2016 |
| K160252 | insulet corporation | OmniPod Insulin Management System | April 27, 2016 |
| K143189 | tandem diabetes care | t:flex Insulin Delivery System | January 9, 2015 |
| K142619 | asante solutions | Snap Insulin Pump System | December 18, 2014 |
| K140439 | insulet corporation | OMNIPOD INSULIN MANAGEMENT SYSTEM | November 13, 2014 |
| K141758 | tandem diabetes care | T:SLIM INSULIN DELIVERY SYSTEM | October 31, 2014 |
| K133593 | tandem diabetes care | T:SLIM INSULIN DELIVERY SYSTEM | March 24, 2014 |
| K131294 | insulet corporation | OMNIPOD INSULIN MANAGEMENT SYSTEM | August 29, 2013 |