# K993200: MD 420/440/460/470/480/490

- Pathway: 510(k) (Traditional)
- Applicant: Isopure, Corp.
- Decided: Jan 24, 2000 after 122 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
Longest line of descent: 1 generation back to K944385 (1995). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944385: MD400 a/B/C/D/E/F/G, International Purification Systems, Inc. (1995) Summary page 3.

## Most influential descendants
- K051620: Matrix Digital Reverse Osmosis Water Treatment System, Model Eqrmd Series (2005), 3 descendants of its own
- K151637: UPT Series Medical RO Water System (2015), 1 descendant of its own
- K250514: UPT Series Medical RO Water Treatment System (2025), 0 descendants of its own
- K161844: Matrix Pre-Treatment Controller (2016), 0 descendants of its own

## Indications for use
The MD 420-490 series reverse osmosis system is intended to purify water for hemodialysis when used as a component of a complete water purification system.

Source page: https://510kreport.com/device/K993200
Methodology: https://510kreport.com/methodology