# K012716: Mainstream Water Purification Device

- Pathway: 510(k) (Traditional)
- Applicant: Prismedical Corp.
- Decided: May 7, 2002 after 265 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: 1 generation back to K002045 (2001). 1 ancestor in all.
10 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002045: Water Purification System for Hemodialysis, Total Water Treatment Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K141731: Nephros Dsu-H, Nephros Ssu-H (2014), 9 descendants of its own
- K153784: Nosogard Filters (2016), 4 descendants of its own
- K153434: Pall-Aquasafe Water Filter (2016), 4 descendants of its own
- K153084: Nephros S100 (2016), 2 descendants of its own
- K191563: FILTRAY 2G Disposable Water Filters (2019), 1 descendant of its own

## Indications for use
To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for: cleaning and rinsing open wounds; infection control (cleaning equipment used in medical procedures, medical personnel’s hands); use as a diluent for enteral, nutritional, oral vaccine or oral drug preparations; and all other uses of sterile purified water the practitioner, or clinician deems necessary. Not for parenteral administration.

Source page: https://510kreport.com/device/K012716
Methodology: https://510kreport.com/methodology