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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
PCCP Authorized No
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 84
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K030531.
PARADIGMPAL, MODEL MMT-7330
K031541 · Minimed, Inc. · Nov 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
MODEL IR 1200 INSULIN PUMP
K032257 · Animas Corp. · Oct 2003
EZMANAGER PLUS
K022394 · Animas Corp. · Jun 2003
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
K023471 · Disetronic Medical Systems AG · Oct 2002
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
K022831 · Disetronic Medical Systems AG · Sep 2002
K030531 · MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
Download PDF FDA Summary Minimed, Inc.