# K974899: Gambro Central Water Treatment System CWP 100 - Wro H

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Healthcare
- Decided: Sep 23, 1998 after 267 days
- Product code: FIP (Subsystem, Water Purification)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931595 (1994). 1 ancestor in all.
14 later devices descend from it; 5 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931595: Reverse Osmosis Equipment for Water Purification, Osmonics, Inc. (1994) Summary page 4.

## Most influential descendants
- 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
- K213507: AquaA (2022), 1 descendant of its own

## Recalls of this device
- Apr 24, 2014 · Class II · Z-1563-2014: Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the 
- Jun 27, 2012 · Class II · Z-1201-2014: There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive hea

## Indications for use
The Gambro Central Water Treatment System CWP 100 — WRO H is designed to produce water of adquate quality for hemodialysis, both chemically and microbiologically with an adequate flow, provided that the feed water complies with the existing standards for drinking water and has been properly pre-treated.

Source page: https://510kreport.com/device/K974899
Methodology: https://510kreport.com/methodology