510(k) · Cleared

Recalled · Class II · 2022

Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers

K160442510(k) TraditionalCleared Oct 21, 2016247-day reviewClass II21 CFR 892.1550Recalls 2

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

Neural Analytics, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 21, 2016 as substantially equivalent to K002533 (Spencer Technologies, 2000) after a 247-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it. It has been recalled 2 times.

Decided: Oct 21, 2016
Review: 247 days
Class: Class II
Product code: IYN
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K002533 (2000). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002533 TCD 100M, PWD13 TransducerSpencer Technologies · 2000 · Recalled
This deviceK160442 Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System)…Neural Analytics, Inc. · 2016
Descendant · cites it directly · 1 of its ownK180455 NeuralBotNeural Analytics, Inc. · 2018 · Recalled
Descendant · 2 generations on · 0 of its ownK213279 NovaGuide 2 Intelligent UltrasoundNovasignal Corporation · 2022 · Recalled

Most influential descendants

Showing 2 of 2 · See all

K180455NeuralBotNeural Analytics, Inc. · 2018 · cites it directly1descendant
K213279NovaGuide 2 Intelligent UltrasoundNovasignal Corporation · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002533	TCD 100M, PWD13 Transducer	Spencer Technologies	2000	1
0 (this device)	K160442	Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz…	Neural Analytics, Inc.	2016	—
+1	K180455	NeuralBot	Neural Analytics, Inc.	2018	1
+2	K213279	NovaGuide 2 Intelligent Ultrasound	Novasignal Corporation	2022	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2022	1	0

FIG. 1 — Lineage of K160442, 2000–2022Source: 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

Get a 510(k) Report

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
*	K002533	TCD 100M, PWD13 Transducer Summary page 8 …ural Analytics Lucid M1 System with 2 MHz transducers Traditional 510(k) Submission Predicate Device K002533 Spencer Technologies, Inc. TCD 100 M, Transcranial Doppler Ultrasound System,…	Spencer Technologies	2000	1

Also cleared against K002533: 6 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K180455	NeuralBot	Neural Analytics, Inc.	2018	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 16, 2022	Class II	Z-1049-2023	Nonconforming Material/Component	Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.
Dec 16, 2022	Class II	Z-1050-2023	Nonconforming Material/Component	Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K180455 (Neural Analytics, Inc., 2018) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K002533.

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. 2016, 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 Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuring and displaying cerebral blood flow velocity within the major conducting arteries and veins of the head and neck. Additionally, The Lucid M1 System measures the occurrence of transient emboli signals within the blood stream.

The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K160442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K160442: Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160442

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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