510(k) · Cleared
Recalled · 2007Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minimed, Inc. · LZG Pump, Infusion, Insulin
Cleared on Jun 17, 2003 after a 118-day review. The FDA summary names its predicate without a number. 20 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 17, 2003
- Review
- 118 days
- Class
- Class II
- Product code
- LZG
- Recalls
- 3
- Predicates
- 0
20 later devices descend from it, 2 citing it directly.
- This deviceK030531 Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD…Minimed, Inc. · 2003
- Descendant · cites it directly · 19 of its ownK040603 Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004
- Descendant · 2 generations on · 15 of its ownK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
- Descendant · 3 generations on · 13 of its ownK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- Descendant · 4 generations on · 10 of its ownK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
- Descendant · 5 generations on · 9 of its ownK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K040603Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004 · cites it directly19descendants
- K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008 · 2 generations on15descendants
- K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012 · 3 generations on13descendants
- K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012 · 4 generations on10descendants
- K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link… | Minimed, Inc. | 2003 | — |
| +1 | K040603 | Paradigm Link Blood Glucose Meter | Becton, Dickinson & CO | 2004 | — |
| +2 | K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | 2008 | — |
| +3 | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| +4 | K121087 | Contour Next Usb Blood Glucose Monitoring System | Bayer Healthcare | 2012 | — |
| +5 | K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Medtronic MiniMed Paradigm Model 511 Insulin Pump Named without a submission number | |
| * | — | BD Logic Glucose Monitor Named without a submission number | |
| * | — | Medtronic MiniMed Model 7304 ComLink Named without a submission number |
What descends from it? (20)
See all 202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 27, 2007 | Not classified | Z-1007-2007 | Other | Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage… |
| Sep 14, 2004 | Not classified | Z-0010-05 | Other | Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed… |
| Jan 29, 2004 | Not classified | Z-0763-04 | Other | 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040603 (Becton, Dickinson & CO, 2004) has gone furthest, with 19 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 Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control.…
Read the full statement (216 words)
The Medtronic MiniMed Paradigm Model 512 Insulin Pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The BD Paradigm Link Blood Glucose Monitor is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
The BD Paradigm Link Blood Glucose Monitor is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the fingertip.
When used together, the BD Paradigm Link Glucose Monitor can automatically telemeter glucose values to the Model 512 Insulin Pump using radio frequency communication. The glucose value received by the Model 512 Insulin Pump is used as the default glucose value by the pump’s Bolus Wizard feature if the Bolus Wizard is used within 12 minutes of the glucose value transmission.
The BD Link Glucose Monitor can also serve as p radio frequency interface to allow communication between the Model 512 Insulin Pump and a personal computer running the appropriate Medtronic MiniMed communications software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030531: Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030531
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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