# K042797: Wro 300 Water Purification System for Hemodialysis

- Pathway: 510(k) (Abbreviated)
- Applicant: Gambro Renal Products
- Decided: Mar 9, 2005 after 152 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K811678 (1981). 1 ancestor in all.
14 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811678: Gambro Water Purification Monitor WRD, Gambro, Inc. (1981) Summary page 1.

## Most influential descendants
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H (2010), 13 descendants of its own
- K110578: Millenium HX Portable Reverse Osmosis Water Purification System (2011), 6 descendants of its own
- K124059: Aquaboss Ecoro Dia I (HT); Aquaboss Ecoro Dia II (HT) (2013), 5 descendants of its own
- K133829: Aquabplus,Aquabplus & Aquabplus B2,Aquabplus&Aquabplus HF,Aquabplus& Aquabplus B2& Aquablus HF (2014), 3 descendants of its own
- K213507: AquaA (2022), 1 descendant of its own

## Indications for use
The Gambro WRO 300 Water Purification System is intended to be used as a dialysis accessory device in conjunction with one dialysis machine to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept.

Source page: https://510kreport.com/device/K042797
Methodology: https://510kreport.com/methodology