Molecular Flow Simulations

FDA 510(k) K201435 · Therataxis, LLC

Substantially Equivalent

510(k) numberK201435

Submission

Device name
Molecular Flow Simulations
Applicant
Therataxis, LLC
Baltimore, MD, US
Received
June 1, 2020
Decision date
December 3, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAW – Neurological Stereotaxic Instrument
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

Other 510(k)s with product code HAW

510(k)DeviceApplicantDecision
K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional Koh Young Technology, Inc.09/10/2026SE
K261932Leksell® Vantage Stereotactic SystemHAW · Traditional Elekta Solutions AB08/05/2026SE
K253663Zeta Navigation SystemHAW · Traditional Zeta Surgical, Inc.05/01/2026SE
K253379Stealth AXiS Cranial clinical applicationHAW · Traditional Medtronic Navigation, Inc.03/26/2026SE
K231897NeuroAlign softwareHAW · Traditional Medivis, Inc.10/21/2025SE
K251317SOLOPASS 2.0 SystemHAW · Traditional Intravent Medical Partners09/05/2025SE
K250893Ball Joint Guide Array (66295)HAW · Traditional Bayer Medical Care, Inc.09/04/2025SE
K250505Ez-FiducialsHAW · Traditional Phasor Health, LLC07/09/2025SE
K242575Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional Brain Navi Biotechnology Co., Ltd.05/23/2025SE
K241327Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional Claronav02/05/2025SE

Questions and answers

When was Molecular Flow Simulations cleared by the FDA?

Molecular Flow Simulations (K201435) received a 510(k) decision of Substantially Equivalent on December 3, 2021, 550 days after the submission was received.

What is the product code of K201435?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.