Data / Medical devices / United States / Probo Medical, Inc.

Probo Medical, Inc.: FDA-registered device maker in Fishers, IN, United States, 2 510(k) clearances

Name: Probo Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Probo Medical, Inc. is registered with the FDA (registration 3012411160) in Fishers, IN, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 10, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012411160
Address: 9715 Kincaid Dr Ste 1000, Fishers, IN, United States, 46037
Owner or operator: Probo Medical, Inc. (10051673)
Roles: Complaint file establishment
First device listed: March 24, 2026
Registered through: 2026
Brand names listed: ACUSON Redwood Diagnostic Ultrasound System, M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9Premium Diagnostic Ultrasound System

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle Guide Kit	OIJ	2	Complaint file establishment	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment	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
June 10, 2021	K210416	M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System	IYN	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	accessdata.fda.gov
April 1, 2021	K210743	ACUSON Redwood Diagnostic Ultrasound System	IYN	Substantially Equivalent	Siemens Medical Solutions USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 10, 2021. 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.