Cleared Traditional

K021974 - MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311

K021974 is an FDA 510(k) clearance for MEDTRONIC MINIMED COMLINK, manufactured by Minimed, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K021974 · Minimed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
50d
Days
Class 2
Risk

K021974 is an FDA 510(k) clearance for the MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Minimed, Inc. (Northridge, US). The FDA issued a Cleared decision on August 6, 2002 after a review of 50 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.

FDA 510(k) Submission Details - K021974

510(k) Number K021974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2002
Decision Date August 06, 2002
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
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 - MRZ Accessories, Pump, Infusion

All 47
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K021974.
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
K051079 · Hospicare, Inc. · May 2005
RITA CLIPS FOR INFUSION PUMPS
K030936 · Rita Medical Systems, Inc. · Apr 2003
PREPARE CARTRIDGE
K023890 · Appro Healthcare, Inc. · Feb 2003
MEDFUSION 2001 & 2010, MODEL N7215IWC
K012259 · National Custom Ent., Inc. · Sep 2001
BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
K012262 · National Custom Ent., Inc. · Sep 2001
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
K012266 · National Custom Ent., Inc. · Sep 2001
K021974 · MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
Download PDF FDA Summary Minimed, Inc.