Cleared Traditional

K960001 - MINIMED INFUSION PUMP, MODEL MMT-507

K960001 is an FDA 510(k) clearance for MINIMED INFUSION PUMP, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K960001 · Medtronic Minimed · General Hospital
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Apr 1996
Decision
119d
Days
Class 2
Risk

K960001 is an FDA 510(k) clearance for the MINIMED INFUSION PUMP, MODEL MMT-507. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Medtronic Minimed (Sylmar, US). The FDA issued a Cleared decision on April 30, 1996 after a review of 119 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 Medtronic Minimed devices

FDA 510(k) Submission Details - K960001

510(k) Number K960001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 02, 1996
Decision Date April 30, 1996
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
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 63
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K960001.
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
K973044 · Disetronic Medical Systems · Sep 1997
MINIMED INFUSION PUMP, MODEL 507C
K972107 · Medtronic Minimed · Aug 1997
MINIMED INSULIN PUMP, MODEL 505
K963948 · Medtronic Minimed · Apr 1997
H-TRON V 100 INSULIN INFUSION PUMP
K905693 · Disetronic Medical Systems · Apr 1991
MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP
K901588 · Medtronic Minimed · Jul 1990
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · Cardiac Pacemakers, Inc. · Feb 1990