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Baxter Innovations & Business Solutions Pvt. Ltd.: FDA-registered device maker in Bangalore Karnataka, India, 5 510(k) clearances

Name: Baxter Innovations & Business Solutions Pvt. Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baxter Innovations & Business Solutions Pvt. Ltd. is registered with the FDA (registration 3015158050) in Bangalore Karnataka, India. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 13, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3015158050
Address: 9th Floor, Crescent 2 Prestige Shanti Niketan, Bangalore Karnataka, India, 560048
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Specification developer
First device listed: December 31, 2017
Registered through: 2027
Brand names listed: Dashboard, Dose IQ Safety Software, Helion Viewer Suite, PrisMax Accessory Auto Effluent, Spectrum IQ Infusion System with Dose IQ Safety Software, Spectrum IQ Infusion System with Dose IQ Safety Software (3570009), Sterile Bag

Devices it lists

Device	Product code	Class	Role	Source
Bed, Ac-Powered Adjustable Hospital	FNL	2	Specification developer	accessdata.fda.gov
Infusion Safety Management Software	PHC	2	Specification developer	accessdata.fda.gov
Monitor, Breathing Frequency	BZQ	2	Specification developer	accessdata.fda.gov
Pump, Infusion	FRN	2	Specification developer	accessdata.fda.gov
System, Hemodialysis, Remote Accessories	MON	1	Specification developer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Specification developer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Specification developer	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
August 13, 2026	K260211	Dashboard (P007000)	MSX	Substantially Equivalent	Hill-Rom, Inc.	accessdata.fda.gov
May 27, 2026	K254265	Helion Viewer Suite	LLZ	Substantially Equivalent	Videomed Srl ( a Baxter Healthcare Corp company)	accessdata.fda.gov
July 28, 2025	K251636	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
March 29, 2024	K230665	Dose IQ Safety Software	PHC	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
May 11, 2018	K173084	Spectrum IQ Infusion System, Dose IQ Safety Software	FRN	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov

Compare with other makers

Updated August 13, 2026. 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.