# K032004: Aquaboss Ecoro Dia 50

- Pathway: 510(k) (Traditional)
- Applicant: Lauer Ltd., Hong Kong
- Decided: Oct 2, 2003 after 94 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 K954928 (1996). 1 ancestor in all.
23 later devices descend from it; 2 cite it directly.
1 of 25 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954928: Portable Reverse Osmosis Machine, Better Water, Inc. (1996) Summary page 1.

## Most influential descendants
- K140866: Tablo Console (2014), 16 descendants of its own
- K150880: Tablo Console with Wireless Capability (2015), 11 descendants of its own
- K160881: Tablo Console (2016), 10 descendants of its own
- K200741: Tablo Hemodialysis System (2020), 7 descendants of its own
- K211370: Tablo Hemodialysis System (2022), 6 descendants of its own

## Indications for use
Aquaboss@EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is a device that is intended for use with a hemodialysis system. It is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. The device includes carbon filter and sediment filter. The device may include a water softener. Aquaboss@EcoRO Dia 50 Portable Water Treatment System for Hemodialysis is designed for the use in hospital or in home settings.

Source page: https://510kreport.com/device/K032004
Methodology: https://510kreport.com/methodology