# K182164: Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand

- Pathway: 510(k) (Special)
- Applicant: Ecolab, Inc.
- Decided: Mar 29, 2019 after 231 days
- Product code: NHV (System, Water Purification, General Medical Use)
- 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
Longest line of descent: 5 generations back to K002045 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173164: Ecolab POU Water Filter, Ecolab, Inc. (2018) Summary page 4.

## Indications for use
The Ecolab POU Water Filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. Ecolab POU Water Filters are suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta. The POU Filters are suitable for general point of use infection control for procedures such as superficial wound cleansing, cleaning of equipment, washing of surgeon’s hands and bathing where the reduction of such microorganisms in the water is desired. The Ecolab POU Filters are not intended for use in the production of USP sterile water for use in infusion, injection or production of fluids for use in dialysis treatments.

Source page: https://510kreport.com/device/K182164
Methodology: https://510kreport.com/methodology