# K030531: Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter

- Pathway: 510(k) (Traditional)
- Applicant: Minimed, Inc.
- Decided: Jun 17, 2003 after 118 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic MiniMed Paradigm Model 511 Insulin Pump: named in the summary without a submission number
- (no number) BD Logic Glucose Monitor: named in the summary without a submission number
- (no number) Medtronic MiniMed Model 7304 ComLink: named in the summary without a submission number

## Most influential descendants
- K040603: Paradigm Link Blood Glucose Meter (2004), 19 descendants of its own
- K073231: Onetouch Ultralink Blood Glucose Monitoring System (2008), 15 descendants of its own
- K110894: Contour Next Link Wireless Blood Glucose Meter (2012), 13 descendants of its own
- K121087: Contour Next Usb Blood Glucose Monitoring System (2012), 10 descendants of its own
- K150942: Contour Next USB Blood Glucose Monitoring System (2015), 9 descendants of its own

## Recalls of this device
- Apr 27, 2007 · Not classified · Z-1007-2007: 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
- Sep 14, 2004 · Not classified · Z-0010-05: 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
- Jan 29, 2004 · Not classified · Z-0763-04: 39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

## Indications for use
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.

Source page: https://510kreport.com/device/K030531
Methodology: https://510kreport.com/methodology