# K944493: Reverse Osmosis System

- Pathway: 510(k) (Traditional)
- Applicant: G.E.M. Water Systems
- Decided: Feb 20, 1996 after 525 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K983618: Dri-Sate Mixer for Preparation of Acidified Dialysate Concentrate (1999), 1 descendant of its own
- K260799: Nipro Dry Acid Concentrate Mixer (2026), 0 descendants of its own
- K153329: MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K944493
Methodology: https://510kreport.com/methodology