# K231410: RenaPure Endotoxin Retentive Filter

- Pathway: 510(k) (Traditional)
- Applicant: Evoqua Water Technologies, LLC
- Decided: Jul 19, 2023 after 65 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 K061782 (2007). 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)
- K061782: Gambro Posiclear, Gambro Services, Inc. (2007) Summary page 4.

## Indications for use
The RenaPure filter is a bacterial and endotoxin retentive filter intended for use in a centralized loop as the final step of a water purification cascade to provide standard dialysis water to machine servicing multiple patients. This filter is not intended to service as the sole means of water purification and therefore must be used in conjunction with other water treatment equipment.

Source page: https://510kreport.com/device/K231410
Methodology: https://510kreport.com/methodology