Waters Medical Systems LLC

Rochester, MN, US

WATERS MEDICAL SYSTEMS, LLC appears in FDA device records in Rochester, MN. FDA records list 3 510(k) clearances between 2012-02-16 and 2013-08-16, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 3
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 3 510(k) clearances for Waters Medical Systems LLC between 2012 and 2013. The busiest year on record is 2013, with 2. The most recent is 2013, with 2.

Clearances by year, as a table

510(k) clearance decisions for Waters Medical Systems LLC, by decision year
Year	Clearances
2012	1
2013	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K121736	PERF-GEN PULSATILE PERFUSION SOLUTION	KDL	Substantially Equivalent	2013-08-16
K121618	BEL-GEN COLD STORAGE SOLUTION	KDL	Substantially Equivalent	2013-06-14
K111521	WAVES	KDN	Substantially Equivalent	2012-02-16

Registered establishments

FDA registered establishments for Waters Medical Systems LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2123774	2123774	WATERS MEDICAL SYSTEMS, LLC	2900 37th St NW, ROCHESTER, MN 55901 US	2026	DQA JJX KDL KDN MSB

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1013-2022	WAVES WCM Kidney Cassette Module	There is a potential for the WCM cassette pump head leaking solution.	Class II	2022-03-21	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Waters Medical Systems LLC edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain