510(k) Report

510(k) · Cleared

Cleared

Medtronic Minimed Carelink Usb Connector, Model NMT 7305

K070438510(k) TraditionalCleared Oct 17, 2007244-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, Inc. · MRZ Accessories, Pump, Infusion

Cleared on Oct 17, 2007 after a 244-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided
Oct 17, 2007
Review
244 days
Class
Class II
Product code
MRZ
Recalls
None
Predicates
0

14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 2 descendants cleared2019: 1 descendant cleared2021: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK070438 Medtronic Minimed Carelink Usb Connector, Model NMT 7305Medtronic Minimed, Inc. · 2007
  2. Descendant · cites it directly · 13 of its ownK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
  3. Descendant · 2 generations on · 10 of its ownK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
  4. Descendant · 3 generations on · 9 of its ownK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
  5. Descendant · 4 generations on · 8 of its ownK160682 CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016
  6. Descendant · 5 generations on · 5 of its ownK193407 Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2012: 22013: 12015: 12016: 22019: 12021: 22022: 12023: 12024: 22026: 1
2012high 2 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all
  • K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012 · cites it directly13descendants
  • K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012 · 2 generations on10descendants
  • K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015 · 3 generations on9descendants
  • K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016 · 4 generations on8descendants
  • K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070438Medtronic Minimed Carelink Usb Connector, Model NMT 7305Medtronic Minimed, Inc.2007—
+1K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare2012—
+2K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare2012—
+3K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare2015—
+4K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care2016—
+5K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201310
201510
201620
201910
202120
202210
202310
202420
202610
FIG. 1 — Lineage of K070438, 2007–2026Source: 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), 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 MRZ? 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 MRZ device

  1. #1 K193654 BlueStar Rxscore 7.5 · 9 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Corn-Link Communication System, Model MMT-7304
Named without a submission number
—

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare201213

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?

  • Of its descendants, K110894 (Bayer Healthcare, 2012) has gone furthest, with 13 descendants of its own.

How does its category compare?

All MRZ devices

MRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MRZ

1in 2023

2007: 22008: 42009: 22010: 22011: 12012: 22013: 12014: 22015: 12016: 22017: 22018: 12019: 12020: 22021: 12022: 12023: 1
2007high 4 (2008) · low 0 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRZ

96in 2008

2008: 96 days median
2007high 96 (2008)2026

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

Recalls per year · MRZ

5in 2019

2009: 12018: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MRZ

35in 2025

2011: 22012: 12015: 1172016: 552017: 182018: 462019: 362020: 442021: 612022: 392023: 272024: 412025: 35
2007high 117 (2015) · low 0 (2007)2025

MAUDE reports naming product code MRZ, 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
20072—00
200849600
20092—10
20102—00
20111—02
20122—01
20131—00
20142—00
20151—0117
20162—055
20172—018
20181—146
20191—536
20202—044
20211—061
20221—039
20231—027
20240—041
20250—035
20260—0—

What is it indicated for?

The Medtronic CareLinkM USB Connector is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes therapy management devices that use Paradigm-compatible RF telemetry and a personal computer that uses data management application software.

Indications for use as stated in the FDA summary.

More from Medtronic Minimed, Inc.

147 FDA decisions under this applicant name. See the company

  • P160017/S140MiniMed 780G SystemMedtronic Minimed, Inc. · 2026
  • P160017/S139MiniMed 770G Insulin Pump; MiniMed 780G Insulin PumpMedtronic Minimed, Inc. · 2026
  • P160017/S138Simplera Sync; Guardian Sensor (3) Transfer to MPROC; MiniMed 780G System with G4SMedtronic Minimed, Inc. · 2026
  • P250012/S011Simplera SyncMedtronic Minimed, Inc. · 2026
  • P250012/S008Simplera Sync SensorMedtronic Minimed, Inc. · 2026

Recent decisions in MRZ

The MRZ category page

  • K230718UTC 3mL Medication CartridgeGilero, LLC · 2023
  • K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions · 2022
  • K201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd. · 2021
  • K193654BlueStar RxWelldoc, Inc. · 2020
  • K191910SpaceStation MRIB. Braun Melsugen AG · 20203 Class I recalls

https://510kreport.com/device/K070438 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070438: Medtronic Minimed Carelink Usb Connector, Model NMT 7305.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070438

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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