Panels › Clinical Chemistry › Product code QFG · Class 2
Alternate Controller Enabled Insulin Infusion Pump
Regulation 880.5730
7510(k)s in 12 months (30 all time)
15recalls in 12 months (24 all time)
24recalls that name a 510(k)
Top companies in QFG
| Company | 510(k)s | Recalls |
|---|---|---|
| Tandem Diabetes Care, Inc. | 10 | 10 |
| Beta Bionics, Inc. | 6 | 3 |
| Medtronic Minimed, Inc. | 3 | 6 |
| Insulet Corporation | 3 | 5 |
| Deka Research and Development | 4 | 0 |
| Deka Research & Development Corp. | 1 | 0 |
| Embecta Medical I, LLC | 1 | 0 |
| Roche Diabetes Care GmbH | 1 | 0 |
| Triple Jump Israel , Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 1014813, 1014936, 1016911, 1016912, 1016913, 1016914, 1018075, 1018 Open, Classified |
QFG | K223213 K233044 +3 |
| Oct 5, 2026 | Medtronic MiniMed, Inc. Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump inte Open, Classified |
QFG | K253743 |
| Sep 29, 2026 | Tandem Diabetes Care, Inc. Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 0038915247 Open, Classified |
QFG | K201214 K203234 +1 |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW Open, Classified |
QFG | K251032 |
| Aug 18, 2026 | Medtronic MiniMed, Inc. MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; Open, Classified |
QFG | K251032 |
| Jul 8, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 Open, Classified |
QFG | K251032 |
| Jun 30, 2026 | Insulet Corporation Omnipod 5 Pods. Includes the below Model/REF Numbers:
1. POD-OMNI-I1-6720.
2. POD-OMNI-I1-6220.
3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod).
4. OMNI-I1-6220.
5. OMNI-I1-6720.
6. BL Open, Classified |
QFG | K231826 |
| Jun 18, 2026 | Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 Open, Classified |
QFG | K252770 |
| Apr 29, 2026 | Beta Bionics, Inc. iLet Bionic Pancreas, REF: BB1001 Open, Classified |
QFG | K252770 |
| Apr 10, 2026 | Insulet Corporation Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Open, Classified |
QFG | K231826 |
| Apr 10, 2026 | Beta Bionics, Inc. iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software Open, Classified |
QFG | K231485 K232224 |
| Apr 2, 2026 | Medtronic MiniMed, Inc. MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) Open, Classified |
QFG | K251032 |
| Mar 25, 2026 | Tandem Diabetes Care, Inc. Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, Open, Classified |
QFG | K232380 K232382 +3 |
| Mar 24, 2026 | Medtronic MiniMed, Inc. MiniMed" 780G - MMT-1884
MiniMed" 780G - MMT-1886
With Software 6.60 and 6.61 Open, Classified |
QFG | K251032 |
| Nov 5, 2025 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump:
Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism Open, Classified |
QFG | K223213 K233044 +2 |
| Oct 23, 2025 | Tandem Diabetes Care, Inc. t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when using Dexcom G7 sensor;
Tandem Mobi insulin pump with Interop Open, Classified |
QFG | K201214 K203234 +2 |
| Sep 24, 2025 | Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) Open, Classified |
QFG | K232380 |
| Aug 27, 2025 | Tandem Diabetes Care, Inc. Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911;
t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;
t: slim X2, Basal-IQ, mg/dl, REF: 1004219;
Pump, t: Open, Classified |
QFG | K193483 K201214 |
| Apr 11, 2025 | Tandem Diabetes Care, Inc. Tandem Mobi Insulin Pump with Interoperable Technology Open, Classified |
QFG | K241078 |
| Apr 11, 2025 | Tandem Diabetes Care, Inc. t:slim X2 Insulin Pump with Interoperable Technology Open, Classified |
QFG | K232380 |
| May 6, 2024 | Tandem Diabetes Care, Inc. t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology Open, Classified |
QFG | K203234 |
| Jan 4, 2024 | Insulet Corporation Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Open, Classified |
QFG | K231826 |
| Sep 20, 2023 | Insulet Corporation Omnipod 5 Automated Insulin Delivery System Open, Classified |
QFG | K203768 |
| Dec 7, 2022 | Insulet Corporation Omnipod 5 Automated Insulin Delivery System
Product catalog numbers:
PT-000409: ASM, Omnipod 5, PDM, Programmed
PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US
PT-000429: Cable, Charg Open, Classified |
QFG | K203768 |
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