Cleared Special

K131517 - MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

K131517 is an FDA 510(k) clearance for MEDRAD TWIST & GO HIGH PRESSURE CONNECT..., manufactured by Medrad, Inc. / Bayer Medical Care, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Special 510(k) pathway after a 66-day FDA review.

K131517 · Medrad, Inc. / Bayer Medical Care, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
66d
Days
Class 2
Risk

K131517 is an FDA 510(k) clearance for the MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Medrad, Inc. / Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on August 2, 2013 after a review of 66 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. 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 - K131517

510(k) Number K131517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date August 02, 2013
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

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 52
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K131517.
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
K063114 · Coeur, Inc. · Feb 2007
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
K131517 · MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
Download PDF FDA Summary Medrad, Inc. / Bayer …