# K983126: Fiberflo Hollow Fiber Capsule Water Filters

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Mar 8, 1999 after 181 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
No predicates in its family tree.
8 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) FiberFlo™ Hollow Fiber Water Filters: named in the summary without a submission number

## Most influential descendants
- K090885: Nephros, Inc., Dsu Dual Stage Ultrafilter (2009), 6 descendants of its own
- K112314: Nephros Olpur H2H Hemodiafiltration (HDF) Module and Olpur MD 220 Hemodiafilter (2012), 5 descendants of its own
- K231534: 5008X Hemodialysis System (2024), 2 descendants of its own
- K243505: 5008X Hemodialysis System (2025), 1 descendant of its own
- K210575: HDF Assist Mudule, HDF Infusion Set and Substitution Filter (2022), 1 descendant of its own

## Indications for use
The FiberFlo™ Capsule Water Filter is intended to filter bacteria, endotoxin and particulate matter from water used for hemodialysis applications.

Source page: https://510kreport.com/device/K983126
Methodology: https://510kreport.com/methodology