Cleared Traditional

K993012 - MINIMED COM-STATION

Also marketed or referenced as:

SOFTWARE-7311

K993012 is the FDA 510(k) clearance for MINIMED COM-STATION by Medtronic Minimed. It is a Class 2 General Hospital device (product code LZG) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K993012 · Medtronic Minimed · General Hospital

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Nov 1999

Decision

68d

Days

Class 2

Risk

K993012 is an FDA 510(k) clearance for the MINIMED COM-STATION, HARDWARE-7301. 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 November 15, 1999 after a review of 68 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	K993012 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Third Party Review (ST)
Date Received	September 08, 1999
Decision Date	November 15, 1999
Days to Decision	68 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

61d faster than avg

Panel avg: 129d · This submission: 68d

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 K993012.

MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP

K041318 · Medtronic Minimed · Jul 2004

MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715

K040676 · Medtronic Minimed · May 2004

DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333

K032164 · Medtronic Minimed · Oct 2003

MINIMED 508 INSULIN PUMP

K990801 · Medtronic Minimed · Jun 1999

MINIMED INFUSION PUMP, MODEL 507C

K972107 · Medtronic Minimed · Aug 1997

MINIMED INSULIN PUMP, MODEL 505

K963948 · Medtronic Minimed · Apr 1997

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 K993012

Medtronic Minimed

Sylmar, CA · US

JENNIFER LYONS

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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