510(k) · Cleared
Recalled · Class II · 2022NeuralBot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neural Analytics, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 22, 2018 as substantially equivalent to K122710 (Shenzhen Delicate Electronics Co., Ltd., 2013) and 1 other predicate after a 91-day review. Its family tree reaches back 4 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- May 22, 2018
- Review
- 91 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K974588 (1998). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK974588 Intra-View Bilateral Transcranial Doppler Device, Smart-Lite…Rimed, Ltd. · 1998
- 3 generations backK060112 Nodecrest Transcranical Doppler Ultrasound SystemNodecrest, LLC · 2006
- 2 generations backK092164 Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers…Shenzhen Delicate Electronics Co., Ltd. · 2010
- 1 generation backK122710 Transcranial Doppler with Robotic Probe HeadbandShenzhen Delicate Electronics Co., Ltd. · 2013
- This deviceK180455 NeuralBotNeural Analytics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK213279 NovaGuide 2 Intelligent UltrasoundNovasignal Corporation · 2022 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K213279NovaGuide 2 Intelligent UltrasoundNovasignal Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974588 | Intra-View Bilateral Transcranial Doppler Device, Smart-Lite Portable… | Rimed, Ltd. | 1998 | — |
| −3 | K060112 | Nodecrest Transcranical Doppler Ultrasound System | Nodecrest, LLC | 2006 | — |
| −2 | K092164 | Transcranial and Vascular Doppler Diagnotic Ultrasound Transducers, Model… | Shenzhen Delicate Electronics Co., Ltd. | 2010 | — |
| −1 | K122710 | Transcranial Doppler with Robotic Probe Headband | Shenzhen Delicate Electronics Co., Ltd. | 2013 | — |
| 0 (this device) | K180455 | NeuralBot | Neural Analytics, Inc. | 2018 | — |
| +1 | K213279 | NovaGuide 2 Intelligent Ultrasound | Novasignal Corporation | 2022 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K122710 | Transcranial Doppler with Robotic Probe HeadbandSummary page 5…NeuralBot System Traditional 510(k) Submission Predicate Devices K122710 Shenzhen Delicate Electronics Co., Ltd. Transcranial Doppler with Robotic… | 2013 |
| * | K160442 | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz TransducersSummary page 5…Class II 21 CFR 892.1550, IYN 21 CFR 892.1570, ITX and OQQ K160442 NEURAL ANALYTICS, INC. Lucid M1 Transcranial Doppler Ultrasound System (L… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213279 | NovaGuide 2 Intelligent Ultrasound | 2022 | 0 |
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-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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K213279 (Novasignal Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122710.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 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 NeuralBot when used with the Lucid M1 System is a medical ultrasound device which assists the user in the setup and acquisition of cerebral blood flow velocity via the patient’s temporal windows. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the blood stream. The NeuralBot is intended to be used by healthcare professionals…
Read the full statement (117 words)
The NeuralBot when used with the Lucid M1 System is a medical ultrasound device which assists the user in the setup
and acquisition of cerebral blood flow velocity via the patient’s temporal windows. It is intended for use as an adjunct to
standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient
emboli within the blood stream.
The NeuralBot is intended to be used by healthcare professionals qualified by training in its safe and effective use. 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/K180455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180455: NeuralBot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180455
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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