510(k) · Cleared

Cleared

Neurovision Ink Printed Endotracheal Tube Electrode

K130806510(k) SpecialCleared Jul 12, 2013109-day reviewClass II21 CFR 874.1820

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

Neurovision Medical Products, Inc. · PDQ Neurosurgical Nerve Locator

Cleared on Jul 12, 2013 as substantially equivalent to K110989 (Neurovision Medical Products, Inc., 2011) after a 109-day review. Its family tree reaches back 6 generations to 1985. 2 of the 16 devices in its family, counting itself, have a Class I recall.

Decided: Jul 12, 2013
Review: 109 days
Class: Class II
Product code: PDQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 6 generations to K851426 (1985). 15 ancestors in all. No later device cites it as a predicate yet. 2 of the 16 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK851426 Accucom Cardiac Output MonitorLawrence Medical Systems, Inc. · 1985
5 generations backK972798 Dynemo 3000Sometec, Inc. · 1998
4 generations backK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
3 generations backK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
2 generations backK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010
1 generation backK110989 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2011 · Recalled
This deviceK130806 Neurovision Ink Printed Endotracheal Tube ElectrodeNeurovision Medical Products, Inc. · 2013

Class I recalls in this family

K050162 Contact Emg Rotatable Endotracheal Tube3 generations back · 2005
K925640 Xomed-Treace Emg Endotracheal Tubeen4 generations back · 1993

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K851426	Accucom Cardiac Output Monitor	Lawrence Medical Systems, Inc.	1985	—
−5	K972798	Dynemo 3000	Sometec, Inc.	1998	—
−4	K021174	Ecom Endotrachial Cardiac Output Monitor	Imagyn Surgical	2003	—
−3	K032491	Ecom CV4 Endotracheal Cardiac Output Monitor	Imagyn Medical Technologies, Inc.	2003	—
−2	K094054	Modifcation to: Nuvasive Neurovision Emg Endotracheal Tube	Nuvasive, Inc.	2010	—
−1	K110989	Neurovision Ink Printed Endotracheal Tube Electrode	Neurovision Medical Products, Inc.	2011	10
0 (this device)	K130806	Neurovision Ink Printed Endotracheal Tube Electrode	Neurovision Medical Products, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1989	1	0
1993	1	1
1994	1	0
1995	1	0
1996	1	0
2001	1	0
2005	1	1
2009	1	0

FIG. 1 — Lineage of K130806, 1985–2013Source: 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.

2 devices in this family have a Class I recall. 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 PDQ device

#1 K243636 Neuralytix iD3 System (NTX-9001)score 16.5 · 14 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? (1)

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
*	K110989	Neurovision Ink Printed Endotracheal Tube Electrode Summary page 1 …ovision Ink Printed Endlotracheal Tube Electrode is substantially equivalent to the following predicate devices concurrently distributed commercially in the U.S.: .K1 10989 Neurovision Ink Printed Endotracheal Tube Electrode Device Description The Neurovision Ink Printed Endlotracheal Tube Electrode…	Neurovision Medical Products, Inc.	2011	10

Also cleared against K110989: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K050162Contact Emg Rotatable Endotracheal TubeMedtronic Xomed, Inc. · 2005 · 3 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
K925640Xomed-Treace Emg Endotracheal TubeenXomed-Treace, Inc. · 1993 · 4 generations back · ◆ in the 1993 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 5.2 years on median.
5 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
2 other devices also cite its predicate K110989.

How does its category compare?

All PDQ devices

PDQ Neurosurgical Nerve Locator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PDQ

1in 2025

2007high 7 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PDQ

182in 2019

2007high 254 (2014) · low 95 (2015)2026

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

Recalls per year · PDQ

No recall names PDQ since 2007.

Adverse event reports per year · PDQ

2in 2025

2007high 16 (2022) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	5	181	1
2014	7	254	0
2015	3	95	1
2016	3	100	4
2017	2	—	5
2018	4	162	5
2019	4	182	10
2020	0	—	9
2021	2	—	10
2022	2	—	16
2023	1	—	9
2024	0	—	4
2025	1	—	2
2026	2	—	—

What is it indicated for?

The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130806 · printed Nov 4, 2026

Cite this page

510(k) Report. “K130806: Neurovision Ink Printed Endotracheal Tube Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130806

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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