# K954928: Portable Reverse Osmosis Machine

- Pathway: 510(k) (Traditional)
- Applicant: Better Water, Inc.
- Decided: Jan 24, 1996 after 90 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
No predicates in its family tree.
24 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032004: Aquaboss Ecoro Dia 50 (2003), 23 descendants of its own
- 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

Source page: https://510kreport.com/device/K954928
Methodology: https://510kreport.com/methodology