Cleared Special

K032642 - BEELINE SYSTEM

K032642 is an FDA 510(k) clearance for BEELINE SYSTEM, manufactured by Mckinley, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 27-day FDA review.

K032642 · Mckinley, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
27d
Days
Class 2
Risk

K032642 is an FDA 510(k) clearance for the BEELINE SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Mckinley, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032642

510(k) Number K032642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2003
Decision Date September 23, 2003
Days to Decision 27 days
Submission Type Special
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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 727
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K032642.
AMBIT CONTINUOUS AMBULATORY INFUSION PUMP
K033325 · Sorenson Medical, Inc. · Nov 2003
AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
K033425 · Sorenson Medical, Inc. · Nov 2003
REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469
K032789 · American I.V. Products, Inc. · Oct 2003
MEDRAD CONTINUUM MR INFUSION SYSTEM
K032771 · Medrad, Inc. · Sep 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · Medtronic Minimed · Aug 2003
BODYGUARD INFUSION SYSTEM
K031749 · Caesarea Medical Electronics , Ltd. · Aug 2003
K032642 · BEELINE SYSTEM
Download PDF FDA Summary Mckinley, Inc.