# K030652: Medro SPD

- Pathway: 510(k) (Traditional)
- Applicant: Usfilter/Ionpure, Inc.
- Decided: Sep 3, 2003 after 187 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K013677 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013677: Modification to: Med-RO Reverse Osmosis System, Usfilter/Ionpure, Inc. (2002) Summary page 1.

## Recalls of this device
- Feb 28, 2005 · Not classified · Z-0798-05: Incorrect type of stainless steel firm used 303 vs 316

## Indications for use
The USFilter MedRO - SPD is a single/acute care patient reverse osmosis unit intended to supply water that is used for hemodialysis treatments. The water produced will meet the minimum water quality requirements as specified by ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD5: 1992 and RD62:2001) and the CSA Water Treatment Equipment and Water Quality Requirements for Hemodialysis (CSA-Z364.2.2-03) when used as directed. Dependent on feed water quality this unit may be used in conjunction with other approved water treatment components.

Source page: https://510kreport.com/device/K030652
Methodology: https://510kreport.com/methodology