# K811678: Gambro Water Purification Monitor WRD

- Pathway: 510(k) (Traditional)
- Applicant: Gambro, Inc.
- Decided: Jul 10, 1981 after 25 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.
28 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have 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
- K042797: Wro 300 Water Purification System for Hemodialysis (2005), 14 descendants of its own
- K093608: Gambro Water Purification Unit, Models Wro 300 and Wro 300 H (2010), 13 descendants of its own
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (2002), 12 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

Source page: https://510kreport.com/device/K811678
Methodology: https://510kreport.com/methodology