# K201435: Molecular Flow Simulations

- Pathway: 510(k) (Traditional)
- Applicant: Therataxis, LLC
- Decided: Dec 3, 2021 after 550 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K983410 (1999). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053164: Iplan Flow, Brainlab AG (2006) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K201435
Methodology: https://510kreport.com/methodology