# K193542: Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22

- Pathway: 510(k) (Traditional)
- Applicant: Bellco Srl
- Decided: Oct 8, 2020 after 293 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
Longest line of descent: 3 generations back to K955592 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030592: Gambro Polyflux, Model 140H, 170H, 210H, Gambro Renal Care Products (2003) Summary page 4.

## Most influential descendants
- K231406: ClearumTM HS (2023), 0 descendants of its own

## Indications for use
The ClearumTM HS dialyzer family is intended for use in acute or chronic renal failure patients requiring hemodialysis.

Source page: https://510kreport.com/device/K193542
Methodology: https://510kreport.com/methodology