Cleared Traditional

K032005 - MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332

K032005 is an FDA 510(k) clearance for MEDTRONIC MINIMED PARADIGM RESERVOIR, manufactured by Medtronic Minimed. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K032005 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
53d
Days
Class 2
Risk

K032005 is an FDA 510(k) clearance for the MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 53 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 - K032005

510(k) Number K032005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2003
Decision Date August 22, 2003
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN 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 - FRN Pump, Infusion

All 848
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K032005.
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469
K032789 · American I.V. Products, Inc. · Oct 2003
BEELINE SYSTEM
K032642 · Mckinley, Inc. · Sep 2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · Medrad, Inc. · Sep 2003
BODYGUARD INFUSION SYSTEM
K031749 · Caesarea Medical Electronics , Ltd. · Aug 2003
CONDUCTION CATHETER
K031600 · Micor, Inc. · Aug 2003
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
K031432 · Hk Surgical, Inc. · Aug 2003
K032005 · MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
Download PDF FDA Summary Medtronic Minimed