LZG · Pump, Infusion, Insulin
General Hospital · 21 CFR 880.5725 · Class 2
Overview
| Product Code | LZG |
|---|---|
| Device Name | Pump, Infusion, Insulin |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 84)
Showing 20 most recent of 84 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253534 | Pivot Insulin Delivery System | Modular Medical | Apr 8, 2026 | SESE |
| K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | Sep 4, 2024 | SESE |
| K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | Jul 2, 2024 | SESE |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | Apr 24, 2023 | SESE |
| K210714 | Extended Reservoir | Medtronic Minimed, Inc. | Apr 6, 2022 | SESE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | Aug 13, 2021 | SESE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | Oct 21, 2019 | SESE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | Jan 8, 2019 | SESE |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | Jun 1, 2018 | SESE |
| K162296 | OmniPod Insulin Management System | Insulet Corporation | Apr 18, 2017 | SESE |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | Oct 25, 2016 | SESE |
| K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | Jul 25, 2016 | SESE |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | Jul 13, 2016 | SESE |
| K160252 | OmniPod Insulin Management System | Insulet Corporation | Apr 27, 2016 | SESE |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | Jan 9, 2015 | SESE |
| K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | Dec 18, 2014 | SESE |
| K140439 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | Nov 13, 2014 | SESE |
| K141758 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | Oct 31, 2014 | SESE |
| K133593 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | Mar 24, 2014 | SESE |
| K131294 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | Aug 29, 2013 | SESE |
Top Applicants
- Medtronic Minimed — 14 clearances
- Insulet Corporation — 12 clearances
- Animas Corp. — 7 clearances
- Tandem Diabetes Care, Inc. — 7 clearances
- Disetronic Medical Systems AG — 6 clearances
