510(k) · Cleared
Recalled · Class I · 2019Minimed 508 Insulin Pump
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 Jun 8, 1999 after a 90-day review. The FDA summary names its predicate without a number. 2 of the 24 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Jun 8, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 2 (1 Class I)
- Predicates
- 0
23 later devices descend from it, 4 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- This deviceK990801 Minimed 508 Insulin PumpMedtronic Minimed · 1999
- Descendant · cites it directly · 10 of its ownK030747 Prodose Aad SystemProfile Therapeutics Plc · 2004
- Descendant · cites it directly · 9 of its ownK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 8 of its ownK133593 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · 2 generations on · 7 of its ownK141758 T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014
- Descendant · 2 generations on · 6 of its ownK042991 I-Neb Aad SystemProfile Therapeutics Plc · 2005
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K111210 T:Slim (TM) Insulin Delivery Systemcites it directly · 2011
Most influential descendants
Showing 5 of 23 · See all- K030747Prodose Aad SystemProfile Therapeutics Plc · 2004 · cites it directly10descendants
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · cites it directly9descendants
- K133593T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · 2 generations on8descendants
- K141758T:Slim Insulin Delivery SystemTandem Diabetes Care, Inc. · 2014 · 2 generations on7descendants
- K042991I-Neb Aad SystemProfile Therapeutics Plc · 2005 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990801 | Minimed 508 Insulin Pump | Medtronic Minimed | 1999 | — |
| +1 | K030747 | Prodose Aad System | Profile Therapeutics Plc | 2004 | — |
| +1 | K111210 | T:Slim (TM) Insulin Delivery System | Tandem Diabetes Care, Inc. | 2011 | Class I |
| +2 | K133593 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +2 | K141758 | T:Slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2014 | — |
| +2 | K042991 | I-Neb Aad System | Profile Therapeutics Plc | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | MiniMed Model 507C Insulin Pump Named without a submission number |
What descends from it? (23)
See all 234 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2019 | Class II | Z-1581-2020 | Device Design | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect… |
| Aug 7, 2018 | Class I | Z-0177-2020 | Software design | There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K030747 (Profile Therapeutics Plc, 2004) has gone furthest, with 10 descendants of its own.
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 MiniMed insulin pump, model 508, is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
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/K990801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990801: Minimed 508 Insulin Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990801
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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