Cleared Traditional

K163114 - Sapphire II PRO

K163114 is an FDA 510(k) clearance for Sapphire II PRO, manufactured by Orbusneich Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K163114 · Orbusneich Medical, Inc. · Cardiovascular device
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Jan 2017
Decision
59d
Days
Class 2
Risk

K163114 is an FDA 510(k) clearance for the Sapphire II PRO. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Orbusneich Medical, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on January 5, 2017 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - the FDA cardiovascular device oversight 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 Orbusneich Medical, Inc. devices

FDA 510(k) Submission Details - K163114

510(k) Number K163114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2016
Decision Date January 05, 2017
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOX Device Classification - Class 2, Special Controls

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 52
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K163114.
Sapphire II PRO
K173680 · Orbusneich Medical Trading, Inc. · Mar 2018
Gallant PTCA Dilatation Catheter
K173581 · Medinol, Ltd. · Jan 2018
Pantera LEO
K163660 · Biotronik, Inc. · Jan 2017
Emerge PTCA Dilatation Catheter
K163174 · Boston Scientific Corporation · Dec 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
K163200 · Boston Scientific Corporation · Dec 2016
Pantera Pro
K160985 · Biotronik, Inc. · Oct 2016