# K031832: Mega Pure Cart

- Pathway: 510(k) (Traditional)
- Applicant: Mega Services
- Decided: Oct 20, 2004 after 495 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 K022747 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022747: Hydropure Portable Exchange Deionization (Pedi) System; Hydropure Back-UP Pedi System, Hydropure Systems, Inc. (2003) Summary page 2.

## Indications for use
The Mega Pure Cart (MPC I), is intended for use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. The MPC is A portable unit and is designed for single patient use only within a Hospital or Clinic setting.

Source page: https://510kreport.com/device/K031832
Methodology: https://510kreport.com/methodology