Usfilter/Ionpure, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Usfilter/Ionpure, Inc. makes
Usfilter/Ionpure, Inc. manufactures reverse osmosis systems designed for water purification, including modifications to existing MED-RO systems and dedicated water purification units for hemodialysis applications. Their portfolio also includes the MEDRO SPD, a specialized device for hemodialysis water treatment.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States, adhering to domestic regulatory requirements for medical water purification systems.
Catalogue
Modification To: Med-Ro Reverse Osmosis System Ref K013677
Regimes: 510(k) Registry: 510(k)Water Purification System For Hemodialysis Ref K980182
Regimes: 510(k) Registry: 510(k)Medro Spd Ref K030652
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Usfilter/Ionpure, Inc., initiated on 2005-02-28. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2005
- 28 Feb 2005 Z-0798-05 Unclassified (pre-2012) Terminated Incorrect type of stainless steel firm used 303 vs 316
Frequently asked questions
How many devices does Usfilter/Ionpure, Inc. have in the registry?
The registry currently lists 3 devices for Usfilter/Ionpure, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Usfilter/Ionpure, Inc.'s devices?
Among its 3 most recently registered devices, Usfilter/Ionpure, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Usfilter/Ionpure, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Usfilter/Ionpure, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Usfilter/Ionpure, Inc.?
FDA recall records list 1 recall initiated by Usfilter/Ionpure, Inc., the most recent initiated on 28 Feb 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Usfilter/Ionpure, Inc. in the registry?
The most recently registered devices listed for Usfilter/Ionpure, Inc. include MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM, WATER PURIFICATION SYSTEM FOR HEMODIALYSIS and MEDRO SPD.