Data / Medical devices / United States / Hill-Rom, Inc.

Hill-Rom, Inc.: FDA-registered device maker in Raleigh, NC, United States, 2 510(k) clearances

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

Hill-Rom, Inc. is registered with the FDA (registration 2027454) in Raleigh, NC, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 16, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Hill-Rom, Inc.

FDA registration number: 2027454
Address: 1501 Nowell Road, Raleigh, NC, United States, 27607
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Complaint file establishment, Manufacturer
First device listed: January 10, 2022
Registered through: 2027
Brand names listed: Voalte Nurse Call OR NaviCare Nurse Call V4.2, Voalte Patient Safety OR NaviCare Patient Safety V4.2, Voalte Smart Sync OR NaviCare V4.1, WAVE Clinical Platform, WAVE Clinical Platform (200)

Devices it lists

Device	Product code	Class	Role	Source
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Monitor, Bed Patient	KMI	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Communication, Powered	ILQ	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
January 16, 2026	K250135	WAVE Clinical Platform (2.0.000)	MWI	Substantially Equivalent	Baxter Healthcare Corp/ Excel Medical	accessdata.fda.gov
January 4, 2018	K171056	WAVE Clinical Platform	MWI	Substantially Equivalent	Excel Medical Electronics, LLC	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
October 14, 2021	88909	Class II	Terminated	These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0 *Product was rebranded from NaviCare to Voalte in 2020	An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.	accessdata.fda.gov
February 14, 2020	85010	Class II	Terminated	NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18	There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.	accessdata.fda.gov

Compare with other makers

Updated January 16, 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.