510(k) · Cleared
ClearedMinimed Insulin Pump, Model 505
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 Apr 8, 1997 as substantially equivalent to K901588 (Medtronic Minimed, 1990) after a 188-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Apr 8, 1997
- Review
- 188 days
- Class
- Class II
- Product code
- LZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901588 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
- This deviceK963948 Minimed Insulin Pump, Model 505Medtronic Minimed · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901588 | Minimed (R) Model 506 External Insulin Pump | Medtronic Minimed | 1990 | — |
| 0 (this device) | K963948 | Minimed Insulin Pump, Model 505 | Medtronic Minimed | 1997 | — |
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? (1)
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 |
|---|---|---|---|
| * | K901588 | Minimed (R) Model 506 External Insulin PumpSummary page 1…011 (v); 818 364-7947 (f); 520 527-0107 (v/f). B. Name of Device: MiniMed Insulin Pump, model 505. C. Predicate Device: MiniMed Insulin Pump, model 506 (cleared: 510(k) K901588). D. Description of Device: The 505 insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery… | 1990 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K901588.
How does its category compare?
All LZG devicesLZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The 505 insulin pump is intended for continuous delivery of insulin for the management of diabetes mellitus in persons requiring exogenous insulin. It is not intended or indicated for the delivery of blood or blood products
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963948: Minimed Insulin Pump, Model 505.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963948
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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