510(k) · Cleared
ClearedExtended Reservoir; MiniMed Reservoir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · LZG Pump, Infusion, Insulin
Cleared on Jul 2, 2024 as substantially equivalent to K001828 (Minimed, Inc., 2000) and 2 other predicates after a 27-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Jul 2, 2024
- Review
- 27 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K032005 (2003). 3 ancestors in all, the oldest K001828 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032005 | Medtronic Minimed Paradigm Reservoir, Model MMT-332 | Medtronic Minimed | 2003 | 1 |
| −1 | K210714 | Extended Reservoir | Medtronic Minimed, Inc. | 2022 | — |
| 0 (this device) | K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZG device
- #1 K253534 Pivot Insulin Delivery Systemscore 16.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001828 | Paradigm 1.5ML Reservoir, Model 326Summary page 4…MiniMed Reservoir 3.0mL (MMT-332A) and Model ID Extended Reservoir (MMT-342, MMT-342G) K001828 Predicate 510(k) Number K032005 K210714 Class II Classification Name… | 2000 |
| * | K032005 | Medtronic Minimed Paradigm Reservoir, Model MMT-332Summary page 4…Reservoir 3.0mL (MMT-332A) and Model ID Extended Reservoir (MMT-342, MMT-342G) K001828 Predicate 510(k) Number K032005 K210714 Class II Classification Name Infusion P… | 2003 |
| * | K210714 | Extended ReservoirSummary page 4…del ID Extended Reservoir (MMT-342, MMT-342G) K001828 Predicate 510(k) Number K032005 K210714 Class II Classification Name Infusion Pump Accessory Pro Code… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 18.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LZG
116in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZG
1in 2022
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · LZG
12,004in 2025
MAUDE reports naming product code LZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 112 | 1 | 5,110 |
| 2008 | 6 | 129 | 13 | 5,711 |
| 2009 | 2 | — | 2 | 9,471 |
| 2010 | 2 | — | 4 | 10,175 |
| 2011 | 4 | 189 | 2 | 12,858 |
| 2012 | 3 | 73 | 4 | 18,367 |
| 2013 | 2 | — | 3 (1) | 30,059 |
| 2014 | 4 | 123 | 2 (1) | 49,188 |
| 2015 | 1 | — | 2 (2) | 69,136 |
| 2016 | 4 | 116 | 0 | 56,581 |
| 2017 | 1 | — | 0 | 44,472 |
| 2018 | 1 | — | 3 (2) | 32,652 |
| 2019 | 2 | — | 5 | 29,027 |
| 2020 | 0 | — | 0 | 32,588 |
| 2021 | 1 | — | 0 | 31,522 |
| 2022 | 1 | — | 1 (1) | 28,225 |
| 2023 | 1 | — | 0 | 21,972 |
| 2024 | 2 | — | 0 | 18,228 |
| 2025 | 0 | — | 0 | 12,004 |
| 2026 | 2 | — | 2 (2) | — |
What is it indicated for?
MiniMed Reservoir- This Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for compatibility.
Extended Reservoir- The Extended Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241622: Extended Reservoir; MiniMed Reservoir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241622
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026