Cleared Traditional

K052431 - MEDTRONIC MINIMED LEAPFROG II INFUSION SET

K052431 is the FDA 510(k) clearance for MEDTRONIC MINIMED LEAPFROG II INFUSION SET by Medtronic Minimed. It is a Class 2 General Hospital device (product code FPK) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K052431 · Medtronic Minimed · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
84d
Days
Class 2
Risk

K052431 is an FDA 510(k) clearance for the MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-.... Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Medtronic Minimed (Northridge, US). The FDA issued a Cleared decision on November 29, 2005 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 K052431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2005
Decision Date November 29, 2005
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPK Tubing, Fluid Delivery

All 20
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K052431.
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
K063239 · Hospira, Inc. · Dec 2006
EMPOWER TRANSFER SET, (CAT. NO. 7725)
K041178 · E-Z-Em, Inc. · Jul 2004
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808 · Medrad, Inc. · Jul 2003
MEDRAD TRANSFER SET
K022431 · Medrad, Inc. · Sep 2002
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · Medtronic Minimed · Feb 1997
RECONSTITUTION ACCESSOREIS
K950861 · Organon, Inc. · May 1995