Data / Medical devices / United States / Baxter Healthcare Corporation

Baxter Healthcare Corporation: FDA-registered device maker in Medina, NY, United States, 2 510(k) clearances

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

Baxter Healthcare Corporation is registered with the FDA (registration 1314492) in Medina, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 28, 2025. 11 recall events name it as the recalling firm (1 Class I). Registered through 2026. 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 Baxter Healthcare Corporation

FDA registration number: 1314492
Address: 711 Park Ave., Medina, NY, United States, 14103
Owner or operator: BAXTER HEALTHCARE CORPORATION (1417572)
Roles: Manufacturer, Specification developer
First device listed: May 14, 2018
Registered through: 2026
Brand names listed: Spectrum IQ Infusion System with Dose IQ Safety Software, Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

Devices it lists

Device	Product code	Class	Role	Source
Infusion Safety Management Software	PHC	2	Manufacturer, Specification developer	accessdata.fda.gov
Pump, Infusion	FRN	2	Manufacturer, 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
July 28, 2025	K251636	Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)	FRN	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

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
March 19, 2021	87568	Class II	Terminated	Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids.	Potentially defective component in the AC power adapter which may fail over time.	accessdata.fda.gov
January 6, 2021	86788	Class II	Terminated	Infusion Pump	Battery performance issues related to prolonged storage.	accessdata.fda.gov
September 18, 2018	81158	Class II	Terminated	SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009	If an operator attempts to manually program a Basic Infusion for a drug that is not included in the Drug Library using the Basic-Dose Mode, the operator will receive a false hard limit exceeded error, preventing him or her from programming the infusion.	accessdata.fda.gov
June 21, 2018	80355	Class II	Terminated	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled	The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusio	accessdata.fda.gov
May 8, 2018	80014	Class II	Terminated	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for th	The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.	accessdata.fda.gov
April 3, 2018	79815	Class II	Terminated	Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration o	Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstre	accessdata.fda.gov
October 6, 2017	79177	Class II	Terminated	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.	Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.	accessdata.fda.gov
January 26, 2017	76364	Class II	Terminated	Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2	SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactl	accessdata.fda.gov
April 23, 2012	61691	Class III	Terminated	SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.	Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.	accessdata.fda.gov
July 6, 2011	61355	Class I	Terminated	Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spe	Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contr	accessdata.fda.gov
September 15, 2010	56833	Not yet classified	Terminated	Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label:	The infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion.	accessdata.fda.gov

Compare with other makers

Updated July 28, 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.