510(k) Report

510(k) · Cleared

Cleared

Minimed (R) Model 506 External Insulin Pump

K901588510(k) TraditionalCleared Jul 2, 199088-day reviewClass II21 CFR 880.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Minimed · LZG Pump, Infusion, Insulin

Cleared on Jul 2, 1990 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 16 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.

Decided
Jul 2, 1990
Review
88 days
Class
Class II
Product code
LZG
Recalls
None
Predicates
0

15 later devices descend from it, 2 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1996: 1 descendant cleared1997: 1 descendant cleared2002: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant cleared2011: 1 descendant cleared, 1 with a Class I recall12014: 2 descendants cleared2016: 3 descendants cleared2015: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants cleared1990200020102020
  1. This deviceK901588 Minimed (R) Model 506 External Insulin PumpMedtronic Minimed · 1990
  2. Descendant · cites it directly · 13 of its ownK960001 Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996
  3. Descendant · 2 generations on · 12 of its ownK013309 Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 11 of its ownK050312 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005
  5. Descendant · 4 generations on · 10 of its ownK071613 Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007
  6. Descendant · 5 generations on · 9 of its ownK111210 T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · Recalled (Class I)

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1996: 11997: 12002: 12005: 12007: 12011: 12014: 22015: 12016: 32024: 12026: 2
1996high 3 (2016) · low 0 (1998)2026

Class I recalls in this family

  • K111210 T:Slim (TM) Insulin Delivery System5 generations on · 2011

Most influential descendants

Showing 5 of 15 · See all
  • K960001Minimed Infusion Pump, Model MMT-507Medtronic Minimed · 1996 · cites it directly13descendants
  • K013309Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc. · 2002 · 2 generations on12descendants
  • K050312Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2005 · 3 generations on11descendants
  • K071613Amigo Insulin PumpNipro Diabetes Systems, Inc. · 2007 · 4 generations on10descendants
  • K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc. · 2011 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901588Minimed (R) Model 506 External Insulin PumpMedtronic Minimed1990—
+1K960001Minimed Infusion Pump, Model MMT-507Medtronic Minimed1996—
+2K013309Glucopro Evo Infusion PumpNipro Diabetes Systems, Inc.20021
+3K050312Amigo Insulin PumpNipro Diabetes Systems, Inc.2005—
+4K071613Amigo Insulin PumpNipro Diabetes Systems, Inc.2007—
+5K111210T:Slim (TM) Insulin Delivery SystemTandem Diabetes Care, Inc.2011Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
200210
200510
200710
201111
201420
201510
201630
202410
202620
FIG. 1 — Lineage of K901588, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has 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. #1 K253534 Pivot Insulin Delivery Systemscore 16.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960001Minimed Infusion Pump, Model MMT-507Medtronic Minimed199613
K963948Minimed Insulin Pump, Model 505Medtronic Minimed19970

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K960001 (Medtronic Minimed, 1996) has gone furthest, with 13 descendants of its own.

How does its category compare?

All LZG devices

LZG Pump, Infusion, Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZG

2in 2024

2007: 32008: 62009: 22010: 22011: 42012: 32013: 22014: 42015: 12016: 42017: 12018: 12019: 22021: 12022: 12023: 12024: 22026 (partial year): 2
2007high 6 (2008) · low 0 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZG

116in 2016

2007: 112 days median2008: 129 days median2011: 189 days median2012: 73 days median2014: 123 days median2016: 116 days median
2007high 189 (2011) · low 73 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZG

1in 2022

2007: 12008: 132009: 22010: 42011: 22012: 42013: 3, 1 Class I2014: 2, 1 Class I2015: 2, 2 Class I2018: 3, 2 Class I2019: 52022: 1, 1 Class I2026 (partial year): 2, 2 Class I
2007high 13 (2008) · low 0 (2016)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · LZG

12,004in 2025

2007: 5,1102008: 5,7112009: 9,4712010: 10,1752011: 12,8582012: 18,3672013: 30,0592014: 49,1882015: 69,1362016: 56,5812017: 44,4722018: 32,6522019: 29,0272020: 32,5882021: 31,5222022: 28,2252023: 21,9722024: 18,2282025: 12,004
2007high 69,136 (2015) · low 5,110 (2007)2025

MAUDE reports naming product code LZG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007311215,110
20086129135,711
20092—29,471
20102—410,175
20114189212,858
2012373418,367
20132—3 (1)30,059
201441232 (1)49,188
20151—2 (2)69,136
20164116056,581
20171—044,472
20181—3 (2)32,652
20192—529,027
20200—032,588
20211—031,522
20221—1 (1)28,225
20231—021,972
20242—018,228
20250—012,004
20262—2 (2)—

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491 FDA decisions under this applicant name. See the company

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Recent decisions in LZG

The LZG category page

  • K262153Pivot Insulin Delivery SystemModular Medical, Inc. · 2026
  • K253534Pivot Insulin Delivery SystemModular Medical · 2026
  • K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc. · 2024
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  • K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation · 2023

https://510kreport.com/device/K901588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K901588: Minimed (R) Model 506 External Insulin Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901588

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026