Cleared Traditional

K963948 - MINIMED INSULIN PUMP, MODEL 505

K963948 is an FDA 510(k) clearance for MINIMED INSULIN 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 188-day FDA review.

K963948 · Medtronic Minimed · General Hospital
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Apr 1997
Decision
188d
Days
Class 2
Risk

K963948 is an FDA 510(k) clearance for the MINIMED INSULIN PUMP, MODEL 505. 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 8, 1997 after a review of 188 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 devices

FDA 510(k) Submission Details - K963948

510(k) Number K963948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received October 02, 1996
Decision Date April 08, 1997
Days to Decision 188 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
59d slower than avg
Panel avg: 129d · This submission: 188d
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 58
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K963948.
MINIMED 508 INSULIN PUMP
K990801 · Medtronic Minimed · Jun 1999
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 INFUSION PUMP, MODEL MMT-507
K960001 · Medtronic Minimed · Apr 1996
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