Cleared Traditional

K070438 - MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305

K070438 is an FDA 510(k) clearance for MEDTRONIC MINIMED CARELINK USB CONNECTOR, manufactured by Medtronic Minimed, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K070438 · Medtronic Minimed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
244d
Days
Class 2
Risk

K070438 is an FDA 510(k) clearance for the MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Medtronic Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on October 17, 2007 after a review of 244 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Minimed, Inc. devices

FDA 510(k) Submission Details - K070438

510(k) Number K070438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2007
Decision Date October 17, 2007
Days to Decision 244 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 129d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 45
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K070438.
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K072955 · Smiths Medical MD, Inc. · Feb 2008
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K071418 · Sooil Development Co., Ltd. · Sep 2007
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
K051079 · Hospicare, Inc. · May 2005
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
K021974 · Minimed, Inc. · Aug 2002