# K160558: Rapido Hollow-Fibre Dialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Bellco Srl
- Decided: Nov 18, 2016 after 263 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: 7 generations back to K001283 (2001). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210, Baxter Healthcare Corporation (2006) Summary page 4.
- K002210: Syntra Dialyzer, Model Syntra 120, 160, Baxter Healthcare Corp (2001) Summary page 4.
- K051520: Gambro Polyflux Hemodialyzer, Model 6H, Gambro Renal Products (2005) Summary page 4.

## Indications for use
The 800 series RAPIDO BLS HOLLOW-FIBRE DIALYZERS are single-use devices intended for hemodialysis (HD), hemofiltration (HF), and hemodiafiltration (HDF) to treat conditions of acute or chronic renal failure when conservative therapy is judged to be inadequate. They are also indicated in the treatment of patients intoxicated with poisons or drugs.

Source page: https://510kreport.com/device/K160558
Methodology: https://510kreport.com/methodology