510(k) Report

510(k) · Cleared

Cleared

Medtronic Micromed 407C Infusion Pump, Model MMT-407C

K043600510(k) TraditionalCleared Mar 29, 200590-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 · FRN Pump, Infusion

Cleared on Mar 29, 2005 as substantially equivalent to K040061 (Medtronic Minimed, 2004) after a 90-day review. Its family tree reaches back 2 generations to 1999. 17 later devices descend from it.

Decided
Mar 29, 2005
Review
90 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K991013 (1999). 17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2010: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2014: 2 descendants cleared2012: 1 descendant cleared2017: 2 descendants cleared2015: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant clearedK991013 · Minimed 407C Infusion Pump, Model 407C · Medtronic Minimed · 1999K040061 · Medtronic Minimed MMT-407C Ambulatory Infusion Pump, Model MMT-407C · Medtronic Minimed · 20041995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K040061 · Medtronic Minimed MMT-407C Ambulatory Infusion Pump, Model MMT-407C · Medtronic Minimed · 2004K991013 · Minimed 407C Infusion Pump, Model 407C · Medtronic Minimed · 19990+5
  1. Root · 2 generations backK991013 Minimed 407C Infusion Pump, Model 407CMedtronic Minimed · 1999
  2. 1 generation backK040061 Medtronic Minimed MMT-407C Ambulatory Infusion Pump, Model MMT-407CMedtronic Minimed · 2004
  3. This deviceK043600 Medtronic Micromed 407C Infusion Pump, Model MMT-407CMedtronic Minimed · 2005
  4. Descendant · cites it directly · 16 of its ownK061110 Glucommander PlusCollaborativemed, LLC · 2006
  5. Descendant · 2 generations on · 13 of its ownK101344 G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010
  6. Descendant · 3 generations on · 12 of its ownK113853 G+ SystemGlytec, LLC · 2012
  7. Descendant · 4 generations on · 8 of its ownK132547 Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · Recalled
  8. Descendant · 5 generations on · 3 of its ownK200443 EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 12010: 12012: 12014: 22015: 12017: 22018: 12020: 22021: 12024: 12026: 2
2006high 2 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all
  • K061110Glucommander PlusCollaborativemed, LLC · 2006 · cites it directly16descendants
  • K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.) · 2010 · 2 generations on13descendants
  • K113853G+ SystemGlytec, LLC · 2012 · 3 generations on12descendants
  • K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies · 2014 · 4 generations on8descendants
  • K200443EndoTool IV 1.10Monarch Medical Technologies, LLC · 2020 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K991013Minimed 407C Infusion Pump, Model 407CMedtronic Minimed1999—
−1K040061Medtronic Minimed MMT-407C Ambulatory Infusion Pump, Model MMT-407CMedtronic Minimed2004—
0 (this device)K043600Medtronic Micromed 407C Infusion Pump, Model MMT-407CMedtronic Minimed2005—
+1K061110Glucommander PlusCollaborativemed, LLC2006—
+2K101344G+ SystemGlytec, LLC (Formally Known AS Glucotec, Inc.)2010—
+3K113853G+ SystemGlytec, LLC2012—
+4K132547Endo Tool Glucose Management System (Egms)Monarch Medical Technologies20141
+5K200443EndoTool IV 1.10Monarch Medical Technologies, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200810
201010
201210
201420
201510
201720
201810
202020
202110
202410
202620
FIG. 1 — Lineage of K043600, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 FRN? 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 FRN device

  1. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K040061Medtronic Minimed MMT-407C Ambulatory Infusion Pump, Model MMT-407C
Summary page 1
…to this submission are identical to those of the predicate device (K040061). The only change is expansion of the indications for use to include intravenous infusion. This change to the indications for us…
Medtronic Minimed2004—
*—SIMS Deltec CADD-Micro, Model 5900
Named without a submission number
—

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061110Glucommander PlusCollaborativemed, LLC200616

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?

  • The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.8 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K061110 (Collaborativemed, LLC, 2006) has gone furthest, with 16 descendants of its own.

How does its category compare?

All FRN devices

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

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

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

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, 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
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The Medtronic MicroMed 407C Drug Infusion Pump is indicated for infusion of medication labeled subcutaneous, intravenous and intrathecal infusion. The pump is intended for therapies at set and variable rates, for therapies including, but not limited to chemotherapy, antibiotic therapy, and controlled analgesia.

Indications for use as stated in the FDA summary.

More from Medtronic Minimed

491 FDA decisions under this applicant name. See the company

  • P150001/S111Medtronic MiniMed 630G System with Guardian Sensor (3); Guardian Sensor (3) Transfer to MPROCMedtronic Minimed · 2026
  • P160007/S063Simplera System; Simplera SyncMedtronic Minimed · 2026
  • P160007/S060Simplera systemMedtronic Minimed · 2026
  • P160007/S062Simplera and Simplera SyncMedtronic Minimed · 2026
  • K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed · 2026

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K043600 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043600: Medtronic Micromed 407C Infusion Pump, Model MMT-407C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043600

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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