Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1314492

FEI Number

1314492

Entity Name

Baxter Healthcare Corporation

City/State/Country

MEDINA, NY, US

Establishment Address

711 PARK AVE., MEDINA, NY 14103, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251636

PMA Number

N/A

All Registered Proprietary Names

Spectrum IQ Infusion System with Dose IQ Safety Software Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2018-05-14
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-05-14
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-07-31

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE
3013836619	Baxter Medical Systems (Suzhou) Co. Ltd	Taicang City Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913718	Abbott Laboratories	PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED	1991-10-30
K840616	Advanced Bio Systems, Inc.	MINI-PUMP U-100	1984-03-30
K850183	Deltec Systems, Inc.	CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M	1985-03-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.
Z-0002-2023	Fresenius Kabi USA, LLC	2	Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
Z-0005-2025	Zyno Medical LLC	2	Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

Similar Registrations

Registration Number	Establishment Name	Location
1018233	C.R. BARD, INC.	COVINGTON, GA, US
1423507	CAREFUSION 2200, INC.	Vernon Hills, IL, US
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US
3007738736	Synergy Health AST, SRL	Alajuela, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1314492. Last updated year: 2026. Please use registration number 1314492 when referencing this establishment in official correspondence.