Cleared Traditional

K101312 - NUVUE COLORMARK9TM) NEEDLE

K101312 is an FDA 510(k) clearance for NUVUE COLORMARK9TM) NEEDLE, manufactured by Nuvue Therapeutics, Inc.. The device is a Class 2 Radiology device with product code IYN cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K101312 · Nuvue Therapeutics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
269d
Days
Class 2
Risk

K101312 is an FDA 510(k) clearance for the NUVUE COLORMARK9TM) NEEDLE. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Nuvue Therapeutics, Inc. (Fairfax, US). The FDA issued a Cleared decision on February 4, 2011 after a review of 269 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuvue Therapeutics, Inc. devices

FDA 510(k) Submission Details - K101312

510(k) Number K101312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2010
Decision Date February 04, 2011
Days to Decision 269 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 107d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYN Device Classification - Class 2, Special Controls

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
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 Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 953
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K101312.
ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K110207 · Aloka Co., Ltd. · Feb 2011
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
K101236 · Ge Healthcare · Feb 2011
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
K110199 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2011
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K103677 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2011
6250 ULTRASOUND SYTEMS
K103152 · Esaote, S.P.A. · Jan 2011
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K103583 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2010