# K231406: ClearumTM HS

- Pathway: 510(k) (Special)
- Applicant: Bellco Srl
- Decided: Jun 14, 2023 after 30 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: 4 generations back to K955592 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193542: Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22, Bellco Srl (2020) Summary page 4.

## Indications for use
The ClearumTM HS 17 is intended for use in acute or chronic renal failure patients requiring hemodialysis

Source page: https://510kreport.com/device/K231406
Methodology: https://510kreport.com/methodology