Product code LZG
- Device name
- Pump, Infusion, Insulin
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.5725
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253534 | Pivot Insulin Delivery System | Modular Medical | 2026-04-08 |
| K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024-09-04 |
| K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | 2024-07-02 |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023-04-24 |
| K210714 | Extended Reservoir | Medtronic Minimed, Inc. | 2022-04-06 |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | 2021-08-13 |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019-10-21 |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019-01-08 |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018-06-01 |
| K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017-04-18 |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | 2016-10-25 |
| K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016-07-25 |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | 2016-07-13 |
| K160252 | OmniPod Insulin Management System | Insulet Corporation | 2016-04-27 |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015-01-09 |
| K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | 2014-12-18 |
| K140439 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2014-11-13 |
| K141758 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-10-31 |
| K133593 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-03-24 |
| K131294 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2013-08-29 |
| K122483 | PEARL DIABETES MANAGEMENT SYSTEM | Asante Solutions, Inc. | 2013-01-03 |
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM | Insulet Corporation | 2012-12-07 |
| K111353 | ACCU-CHECK COMBO SYSTEM | Roche Diagnostics | 2012-07-17 |
| K120206 | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS | Medtronic Minimed | 2012-03-29 |
| K111669 | FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS | Insulet Corporation | 2011-12-15 |
| K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2011-11-09 |
| K100567 | PEARL DIABETES MANAGEMENT SYSTEM | M2 Group Holdings, Inc. | 2011-05-10 |
| K103825 | V-GO INSULIN DELIVERY SYSTEM | Valeritas, Inc. | 2011-02-23 |
| K100504 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 | Valeritas, LLC | 2010-12-01 |
| K093364 | SOLO MICROPUMP INSULIN DELIVERY SYSTEM | Medingo , Ltd. | 2010-01-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10385084000403 | Omnipod Go Insulin Delivery Device 40U/day | Insulet Corporation | 2023-08-18 |
| 10385084000359 | Omnipod Go Insulin Delivery Device 35U/day | Insulet Corporation | 2023-08-18 |
| 10385084000304 | Omnipod Go Insulin Delivery Device 30U/day | Insulet Corporation | 2023-08-18 |
| 10385084000250 | Omnipod Go Insulin Delivery Device 25U/day | Insulet Corporation | 2023-08-18 |
| 10385084000205 | Omnipod Go Insulin Delivery Device 20U/day | Insulet Corporation | 2023-08-18 |
| 10385084000151 | Omnipod Go Insulin Delivery Device 15U/day | Insulet Corporation | 2023-08-18 |
| 10385084000106 | Omnipod Go Insulin Delivery Device 10U/day POD | Insulet Corporation | 2023-08-18 |
| 08809220580000 | Superline | SOOIL DEVELOPMENT CO.,LTD | 2023-06-14 |
| 20763000497181 | Extended Reservoir | MEDTRONIC MINIMED, INC. | 2022-09-09 |
| 00373108000013 | CeQur Simplicity | CEQUR CORPORATION | 2021-08-22 |
| 00373108000006 | CeQur Simplicity | CEQUR CORPORATION | 2021-08-22 |
| 10385082000023 | Omnipod DASH Pod | Insulet Corporation | 2018-08-01 |
| 10385081120012 | Omnipod | Insulet Corporation | 2018-03-05 |
| 00353885011679 | OneTouch Ping | LifeScan Europe GmbH | 2017-12-14 |
| 00353885010207 | OneTouch Ping | ANIMAS CORPORATION | 2017-09-13 |
| 10385081140003 | Omnipod | Insulet Corporation | 2016-09-23 |
| 08809220580789 | DANA Diabecare | SOOIL DEVELOPMENT CO.,LTD | 2016-08-24 |
| 10840406100976 | OneTouch Ping | ANIMAS CORPORATION | 2016-08-18 |
| 10840406100839 | OneTouch Ping | ANIMAS CORPORATION | 2016-08-18 |
| 08809220580413 | Soft-Release-ST | SOOIL DEVELOPMENT CO.,LTD | 2016-08-12 |
| 08809220580406 | Soft-Release-ST | SOOIL DEVELOPMENT CO.,LTD | 2016-08-12 |
| 08809220580086 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580178 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580185 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580192 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580246 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580253 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580260 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580277 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |
| 08809220580284 | Easy Release | SOOIL DEVELOPMENT CO.,LTD | 2016-08-11 |