Cleared Traditional

K031541 - PARADIGMPAL, MODEL MMT-7330

K031541 is an FDA 510(k) clearance for PARADIGMPAL, 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 186-day FDA review.

K031541 · Minimed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
186d
Days
Class 2
Risk

K031541 is an FDA 510(k) clearance for the PARADIGMPAL, MODEL MMT-7330. 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 November 18, 2003 after a review of 186 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.

FDA 510(k) Submission Details - K031541

510(k) Number K031541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2003
Decision Date November 18, 2003
Days to Decision 186 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
57d slower than avg
Panel avg: 129d · This submission: 186d
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 K031541.
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
IXL DIABETES MANAGEMENT SYSTEM
K031373 · Insulet Corp. · Dec 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
MODEL IR 1200 INSULIN PUMP
K032257 · Animas Corp. · Oct 2003
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER
K030531 · Minimed, Inc. · Jun 2003
K031541 · PARADIGMPAL, MODEL MMT-7330
Download PDF FDA Summary Minimed, Inc.