Cleared Traditional

K060119 - MCKINLEY SATURATION CATHETER

K060119 is an FDA 510(k) clearance for MCKINLEY SATURATION CATHETER, manufactured by Mckinley Medical, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K060119 · Mckinley Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
85d
Days
Class 2
Risk

K060119 is an FDA 510(k) clearance for the MCKINLEY SATURATION CATHETER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Mckinley Medical, LLC (Wheat Ridge, US). The FDA issued a Cleared decision on April 12, 2006 after a review of 85 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 Mckinley Medical, LLC devices

FDA 510(k) Submission Details - K060119

510(k) Number K060119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2006
Decision Date April 12, 2006
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
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 549
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K060119.
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
K062700 · B.Braun Medical, Inc. · Oct 2006
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K061128 · Medrad, Inc. · May 2006
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087
K060806 · Hospira, Inc. · Apr 2006
WILLCARE, MODEL GW-1020
K052594 · Icu Medical, Inc. · Feb 2006
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER
K053226 · Zimmer, Inc. · Jan 2006
CADD-MS 3 AMBULATORY INFUSION PUMP
K051568 · Smiths Medical MD, Inc. · Nov 2005