Cleared Traditional

K972107 - MINIMED INFUSION PUMP

K972107 is the FDA 510(k) clearance for MINIMED INFUSION PUMP by Medtronic Minimed. It is a Class 2 General Hospital device (product code LZG) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K972107 · Medtronic Minimed · General Hospital

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Aug 1997

Decision

71d

Days

Class 2

Risk

K972107 is an FDA 510(k) clearance for the MINIMED INFUSION PUMP, MODEL 507C. 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 August 15, 1997 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Minimed devices

Submission Details

510(k) Number	K972107 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Third Party Review (ST)
Date Received	June 05, 1997
Decision Date	August 15, 1997
Days to Decision	71 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

58d faster than avg

Panel avg: 129d · This submission: 71d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 29

Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K972107.

DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333

K032164 · Medtronic Minimed · Oct 2003

MINIMED COM-STATION, HARDWARE-7301

K993012 · Medtronic Minimed · Nov 1999

MINIMED 508 INSULIN PUMP

K990801 · Medtronic Minimed · Jun 1999

MINIMED INSULIN PUMP, MODEL 505

K963948 · Medtronic Minimed · Apr 1997

MINIMED INFUSION PUMP, MODEL MMT-507

K960001 · Medtronic Minimed · Apr 1996

MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP

K901588 · Medtronic Minimed · Jul 1990

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K972107

Medtronic Minimed

Sylmar, CA · US

DON SELVEY

Regulatory profile

49 submissions 44 cleared

90% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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