Who else makes this device?

Name: Waves Control Unit
Brand: Waves Control Unit

Gastroenterology & Urology › TherapeuticSystem, Perfusion, Kidney

Waves Control Unit

The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitoring software. WMS designed the device…

Registry build 21.09.26

The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitoring software. WMS designed the device with an ice/water backup system along with battery back-up power. These systems allow for transport or remote monitoring if customers decide this is necessary. Donor paperwork and typing materials, biopsy slides, and other specimens can be transported securely with the kidney using the system. The system provides optimal preservation while increasing the user’s ability to assess parameters. Our goal is to assist the OPO and transplant center by improving DGF rates and patient outcomes following transplantation.

1manufacturer

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KDN
Manufacturer	City	Province	Registered as	Device types
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16

Record

Regulatory record for Waves Control Unit
Listed by	Waters Medical Systems, LLC, United States
FDA product code	KDN
Device type	System, Perfusion, Kidney
Device class	Class 2
Regulation	21 CFR 876.5880
Establishment	Complaint-file establishment, Manufacturer
510(k)	K111521
Record published	2017-02-12
Record revised	2023-12-18 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Distribution end date	2023-12-15

Catalogue Numbers

Catalogue numbers for Waves Control Unit
Catalogue number	Size	Status
WAVES CONTROL UNIT		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BAROguard	Paragonix Technologies, Inc.	7
LifePort® Kidney Transporter	Organ Recovery Systems, Inc.	5
KidneyVault	Paragonix Technologies, Inc.	5
KidneyVault Portable Renal Perfusion System	Paragonix Technologies, Inc.	3
PancreasPak	Paragonix Technologies, Inc.	3
Perfadex Plus®	Xvivo Perfusion AB	3
Perfusion Cannula	Institut Georges Lopez	3
Belzer UW Cold Storage Solution	Bridge to Life Ltd	3
Belzer UW Cold Storage Solution	Preservation Solutions, Inc.	3
X°Port Lung Preservation Solution	Traferox Technologies Inc.	3
LUNGguard	Paragonix Technologies, Inc.	2
Servator B Salf Solution	S.a.l.f. SPA Laboratorio Farmacologico	2

Showing 12 of 78. All products under System, Perfusion, Kidney

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111521	2012-02-16

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Waves Control Unit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Waters Medical Systems, LLC	510(k) number	2022-03-21	Class II	Process control	There is a potential for the WCM cassette pump head leaking solution.	75 cases (6ct)	2024-08-16

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.