510(k) · Cleared

Cleared

Nuvue COLORMARK9TM) Needle

K101312510(k) TraditionalCleared Feb 4, 2011269-day reviewClass II21 CFR 892.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nuvue Therapeutics, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Feb 4, 2011 as substantially equivalent to K031173 (Needle Tech Products, Inc., 2003) and 1 other predicate after a 269-day review. Its family tree reaches back 1 generation to 1993.

Decided: Feb 4, 2011
Review: 269 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K926351 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK926351 Colormark (TM) Visualization SystemEchocath, Inc. · 1993
This deviceK101312 Nuvue COLORMARK9TM) NeedleNuvue Therapeutics, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926351	Colormark (TM) Visualization System	Echocath, Inc.	1993	—
0 (this device)	K101312	Nuvue COLORMARK9TM) Needle	Nuvue Therapeutics, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K101312, 1993–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYN device

#1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K031173	Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013 Summary page 1 …1. Legally marketed Predicate Devices The NuVue ColorMark" Needle is substantially equivalent to the EchoTip Needle Guidewire Introducer Needle (K031173) for ultrasound imaging visibility and to the ColorMark TM Visualization System (K926351) for Color flow-Doppler Ultras…	Needle Tech Products, Inc.	2003	—
*	K926351	Colormark (TM) Visualization System Summary page 1 …quivalent to the EchoTip Needle Guidewire Introducer Needle (K031173) for ultrasound imaging visibility and to the ColorMark TM Visualization System (K926351) for Color flow-Doppler Ultrasound imaging visibility. 11. Intended Use Indications for Use: The NuVue C…	Echocath, Inc.	1993	—

Also cleared against K031173: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K031173.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	26	16	3
2008	25	18	12	2
2009	18	29	8	9
2010	29	67	10	17
2011	39	46	8	18
2012	43	37	3	20
2013	51	60	8	18
2014	56	39	2	48
2015	54	55	3	116
2016	60	56	2	145
2017	64	83	0	146
2018	59	85	7	85
2019	47	79	0	59
2020	57	72	4	67
2021	46	105	8	213
2022	53	105	10	186
2023	44	115	4	229
2024	50	119	1	266
2025	57	124	10	610
2026	44	107	2 (1)	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101312 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101312: Nuvue COLORMARK9TM) Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101312

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026