Cleared Abbreviated

K063114 - DISPOSABLE TRANSFER SETS WITH AND WITHO...

K063114 is an FDA 510(k) clearance for DISPOSABLE TRANSFER SETS WITH AND WITHO..., manufactured by Coeur, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Abbreviated 510(k) pathway after a 121-day FDA review.

K063114 · Coeur, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
121d
Days
Class 2
Risk

K063114 is an FDA 510(k) clearance for the DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Coeur, Inc. (Lebanon, US). The FDA issued a Cleared decision on February 9, 2007 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Coeur, Inc. devices

FDA 510(k) Submission Details - K063114

510(k) Number K063114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2006
Decision Date February 09, 2007
Days to Decision 121 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Standards-based clearance path.

FPK Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K063114.
LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
K063239 · Hospira, Inc. · Dec 2006
MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
K052431 · Medtronic Minimed · Nov 2005
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