Data / Medical devices / United States / Phasor Health, LLC

Phasor Health, LLC: FDA-registered device maker in Houston, TX, United States, 6 510(k) clearances

Name: Phasor Health, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Phasor Health, LLC is registered with the FDA (registration 3016577622) in Houston, TX, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 21, 2025. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016577622
Address: 8944 Kirby Drive, Houston, TX, United States, 77054
Owner or operator: Phasor Health, LLC (10062497)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: February 3, 2020
Registered through: 2026
Brand names listed: EVAC, EVAC-MRI, EZ-Fiducials, Green, LEGACY, PHASOR, Phasor Kit

Devices it lists

Device	Product code	Class	Role	Source
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Neurological Tray	OJG	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Shunt, Central Nervous System And Components	JXG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 21, 2025	K252696	LEGACY	HBG	Substantially Equivalent	Phasor Health, LLC	accessdata.fda.gov
November 5, 2025	K252514	EVAC-MRI	JXG	Unknown	Phasor Health, LLC	accessdata.fda.gov
October 31, 2025	K252060	GREEN	HBE	Substantially Equivalent	Phasor Health, LLC	accessdata.fda.gov
July 9, 2025	K250505	EZ-FIDUCIALS	HAW	Substantially Equivalent	Phasor Health, LLC	accessdata.fda.gov
June 3, 2025	K243205	EVAC	JXG	Substantially Equivalent	Phasor Health, LLC	accessdata.fda.gov
December 1, 2016	K161704	Phasor Drill	HBE	Substantially Equivalent	Biotex, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 21, 2025	97089	Class II	Ongoing	Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35	Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.	accessdata.fda.gov

Compare with other makers

Updated November 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.