# K101312: Nuvue COLORMARK9TM) Needle

- Pathway: 510(k) (Traditional)
- Applicant: Nuvue Therapeutics, Inc.
- Decided: Feb 4, 2011 after 269 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K926351 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031173: Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013, Needle Tech Products, Inc. (2003) Summary page 1.
- K926351: Colormark (TM) Visualization System, Echocath, Inc. (1993) Summary page 1.

## Indications for use
The NuVue ColorMarkM Needle is intended for use when one desires the visualization of an interventional needle (e.g. biopsy needle) on B-scan ultrasound screens which have color flow Doppler imaging capability. The NuVue ColorMarkTMNeedle is indicated for use in clinical applications and at anatomical sites for which the biopsy needle and the ultrasound system have received marketing clearance by the FDA.

Source page: https://510kreport.com/device/K101312
Methodology: https://510kreport.com/methodology