# K993806: Dialguard Endotoxin Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Clarigen, Inc.
- Decided: Aug 14, 2000 after 279 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 K945136 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945136: Renaguard Dialysate Filter, Minntech Corp. (1995) Summary page 2.

## Most influential descendants
- K052764: Diacap Ultra Dialysis Fluid Filter (2006), 0 descendants of its own

## Indications for use
The DialGuard™ device is intended to be used for the reduction of endotoxin from: 1. Dialysate prior to entering the dialyser 2. Water prior to its use for preparation of dialysate 3. Water prior to use for regenerating dialysers. DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard ™ will consistently reduce endotoxin levels to € 0.05 EU/mL. (AAMI standard for water for dialysate is < 5.0 EU/mL. Currently, there are no standards set for dialysate).

Source page: https://510kreport.com/device/K993806
Methodology: https://510kreport.com/methodology