Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004906872

FEI Number

3004906872

Entity Name

InfuSystem Inc.

City/State/Country

Lenexa, KS, US

Establishment Address

11130 Strang Line Rd., Lenexa, KS 66215, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

InfuSystem Inc. (Owner Number: 10029405)

Owner / Operator Contact Address

11130 Strang Line Rd., Lenexa, KS 66215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092313

PMA Number

N/A

All Registered Proprietary Names

CADD Legacy PCA Alaris 8015 CADD High Volume Admin Set CADD Prizm Model 6100 Pump Spectrum & Spectrum with Master Drug Library CADD Legacy One Infinity Bags 20, 100, 1200 ML Infusomat Space Alaris 8110 CADD Legacy Plus Cadd Prizm Power Pack Vista Basic Curlin 6000 Smiths CADD Cassette Reservoir 500 ML Bag Enteralite Infinity Set Medfusion 3500 Syringe Pump Q CORE Sapphire Pump Baxter Sigma Spectrum Infusion Pump with Master Drug Library CADD Administration Set Cadd Solis Ambulatory Pump Perfusor Space

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2015-06-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-07-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-11-22
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2015-06-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2015-07-22
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-12-21
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2020-04-21
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-08
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2019-05-03
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2015-06-30
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-08
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-04-28
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-07-26
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-11-22
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2020-04-21
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-08-28
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2021-01-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2021-01-27
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2017-02-08
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2017-02-08
QUA	Intraoral Cooling Device	Dental	Class 2	872.5590	2025-06-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-11-22
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2018-05-22
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2018-05-22
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2019-05-03
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2019-05-03

Official Correspondent

Melissa Mackey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InfuSystem Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012337868	InfuSystem Inc.	Mississauga Ontario, CA

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
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2012	Smiths Medical ASD, Inc.	2	Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion.
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
Z-0006-2011	CareFusion Corporation	2	CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.

Similar Registrations

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3010381606	EMSERE BV	Leiden Zuid-Holland, NL
3003879246	CareFusion 303, INC	San Diego, CA, US
3012337868	InfuSystem Inc.	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004906872. Last updated year: 2026. Please use registration number 3004906872 when referencing this establishment in official correspondence.