# K931595: Reverse Osmosis Equipment for Water Purification

- Pathway: 510(k) (Traditional)
- Applicant: Osmonics, Inc.
- Decided: Dec 29, 1994 after 638 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.
16 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974899: Gambro Central Water Treatment System CWP 100 - Wro H (1998), 14 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
- K093641: TANGO3 Water Storage Tank with Ozone Disinfection System (2010), 3 descendants of its own
- K131904: Mediqa Single Pass Reverse Osmosis System with Heat Sanitization, Mediqa Double Pass Reverse Osmosis System with Heat SA (2013), 2 descendants of its own

Source page: https://510kreport.com/device/K931595
Methodology: https://510kreport.com/methodology