# K153784: Nosogard Filters

- Pathway: 510(k) (Traditional)
- Applicant: Evoqua Water Technologies, LLC
- Decided: Oct 21, 2016 after 295 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: 3 generations back to K002045 (2001). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141731: Nephros Dsu-H, Nephros Ssu-H, Nephros, Inc. (2014) Summary page 4.
- K012716: Mainstream Water Purification Device, Prismedical Corp. (2002) Summary page 4.

## Most influential descendants
- K191563: FILTRAY 2G Disposable Water Filters (2019), 1 descendant of its own
- K173164: Ecolab POU Water Filter (2018), 1 descendant of its own
- K261470: QF10 (2026), 0 descendants of its own
- K182164: Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand (2019), 0 descendants of its own

## Indications for use
The NOSOGARD line of filters are intended to operate on EPA quality drinking water sources as a microbial retention filter. NOSOGARD filters are available in models suitable for the control of bacteria equal to or greater in size than Brevundimons diminuta and models for microbial removal equal to or greater than Legionella pneumophila. The NOSOGARD is suitable for general point of use infection control for procedures such as cleaning, rinsing of equipment, hand washing and bathing where the reduction of such microorganisms in the water is desired. The Nosogard is 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/K153784
Methodology: https://510kreport.com/methodology