510(k) · Cleared
ClearedMolecular Flow Simulations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therataxis, LLC · HAW Neurological Stereotaxic Instrument
Cleared on Dec 3, 2021 as substantially equivalent to K053164 (Brainlab AG, 2006) after a 550-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Dec 3, 2021
- Review
- 550 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983410 (1999). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −3 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −2 | K041330 | Iplan! Flow | Brainlab AG | 2004 | — |
| −1 | K053164 | Iplan Flow | Brainlab AG | 2006 | — |
| 0 (this device) | K201435 | Molecular Flow Simulations | Therataxis, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K053164 | Iplan FlowSummary page 4…n Flow Predicate Device Manufacturer: Brainlab AG Predicate Device Common Name: iPlan Flow Predicate Device Premarket Notification # K053164 Predicate Device Classification & Name Classification: Class II Name: Stere… | 2006 |
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?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI)-data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial…
Read the full statement (175 words)
Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI)-data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial catheters. Guidelines for the catheter placement, such as from catheter suppliers, can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. Molecular Flow Simulations does not generate or create rules for the placement of intracranial catheters by any means. Molecular Flow Simulations uses MR-DTI and T2- weighted MR images to suggest likely volumes of fluid distribution.
The primary mode of action for Molecular Flow Simulations is a device for creating stereotactic or image-guided surgical plans, especially for the creation of plans for the placement of intracranial catheters.
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/K201435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201435: Molecular Flow Simulations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201435
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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