Evoqua Water Technologies LLC

Indianapolis, IN, US

Evoqua Water Technologies LLC appears in FDA device records in Indianapolis, IN. FDA records list 6 510(k) clearances between 2011-05-20 and 2023-07-19, no PMA records and 2 registered establishments. As of 2026-09-10, FDA records show 3 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 6
PMA records: 0
Recall records: 3
Registered establishments: 2

FDA records under these names

1 name

FDA records resolved to Evoqua Water Technologies LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Mar Cor Purification, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 6 510(k) clearances for Evoqua Water Technologies LLC between 2011 and 2023. The busiest year on record is 2011, with 1. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for Evoqua Water Technologies LLC, by decision year
Year	Clearances
2011	1
2014	1
2016	1
2019	1
2020	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K231410	RenaPure Endotoxin Retentive Filter	FIP	Substantially Equivalent	2023-07-19
K200670	EON Portable RO Water Purification System	FIP	Substantially Equivalent	2020-04-16
K192398	Millenium HX	FIP	Substantially Equivalent	2019-10-03
K153784	NOSOGARD FILTERS	NHV	Substantially Equivalent	2016-10-21
K133149	BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM	FIP	Substantially Equivalent	2014-04-30
K110578	MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM	FIP	Substantially Equivalent	2011-05-20

Registered establishments

FDA registered establishments for Evoqua Water Technologies LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004057358	3004057358	Evoqua Water Technologies LLC	6125 Guion Road, Indianapolis, IN 46254 US	2026	FIP
3019131	3006475063	Evoqua Water Technologies LLC	14550 28TH AVENUE NORTH, Minneapolis, MN 55447 US	2026	FIN FIP KPO LIF LRJ NII

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-1563-2014	Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.	Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water.	Class II	2014-04-24	Terminated
Z-1213-2014	Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..	High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.	Class II	2013-06-26	Terminated
Z-1201-2014	Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.	There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.	Class II	2012-06-27	Terminated

Verification record

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