Cleared Traditional

K030531 - MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER

K030531 is an FDA 510(k) clearance for MEDTRONIC MINIMED PARADIGM MODEL 512 IN..., manufactured by Minimed, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K030531 · Minimed, Inc. · General Hospital
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Jun 2003
Decision
118d
Days
Class 2
Risk

K030531 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GL.... Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on June 17, 2003 after a review of 118 days - within the typical 510(k) review window.

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 Minimed, Inc. devices

FDA 510(k) Submission Details - K030531

510(k) Number K030531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date June 17, 2003
Days to Decision 118 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZG Device Classification - Class 2, Special Controls

Product Code LZG Pump, Infusion, Insulin
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 - LZG Pump, Infusion, Insulin

All 53
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K030531.
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738 · Smiths Medical MD, Inc. · May 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676 · Medtronic Minimed · May 2004
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
R1000 SERIES INSULIN PUMP
K993184 · Animas Corp. · Feb 2000
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · Disetronic Medical Systems · Dec 1999
MINIMED COM-STATION, HARDWARE-7301
K993012 · Medtronic Minimed · Nov 1999