# K910236: Renaflo HDF 1350 Hemodiafilter

- Pathway: 510(k) (Traditional)
- Applicant: Minntech Corp.
- Decided: Apr 9, 1991 after 81 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982134: Dynamic Hollow Fiber Dialyzer DS-Series Model as-851 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K910236
Methodology: https://510kreport.com/methodology