Data / Medical devices / United States / Redstone Healthcare LLC

Redstone Healthcare LLC: FDA-registered device maker in Lake Forest, IL, United States, 6 510(k) clearances

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

Redstone Healthcare LLC is registered with the FDA (registration 3010952312) in Lake Forest, IL, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 9, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3010952312
Address: 825 S Waukegan Road A8 #161, Lake Forest, IL, United States, 60045
Owner or operator: Redstone Healthcare LLC (10048374)
Roles: Complaint file establishment, Repackager or relabeler
First device listed: May 7, 2020
Registered through: 2026
Brand names listed: ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND, EPIQ Cvx and Series Diagnostic Ultrasound System; Affiniti Cvx and Series Diagnostic Ultrasound System

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Repackager or relabeler	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
October 9, 2025	K251651	EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, LLC	accessdata.fda.gov
July 27, 2018	K181485	EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Philips Ultrasound, Inc.	accessdata.fda.gov
August 17, 2016	K152126	UST-5550-R; UST-5536-R; L43K	ITX	Substantially Equivalent	Hitachi Aloka Medical America, Inc.	accessdata.fda.gov
March 28, 2014	K134016	ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER	IYN	Substantially Equivalent	Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical	accessdata.fda.gov
July 12, 2005	K051263	EVITAXL WITH OPTION SMARTCARE	CBK	Substantially Equivalent	Drager Medical AG & Co. Kgaa	accessdata.fda.gov
August 24, 1999	K992608	ATC OPTION FOR EVITA 2 DURA AND EVITA 4	CBK	Substantially Equivalent	Drager, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 9, 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.