# K052218: Crono Five and Crono Pca 50

- Pathway: 510(k) (Traditional)
- Applicant: Cane S.R.L.
- Decided: Nov 23, 2005 after 100 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K982838 (1998). 3 ancestors in all.
2 later devices descend 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)
- K041414: Crono and Crono, Model 30, Cane S.R.L. (2004) Summary page 1.

## Most influential descendants
- K091042: Crono S-Pid 50 (2009), 1 descendant of its own
- K251105: Tetra (TM-20); Tetra (TM-50) (2025), 0 descendants of its own

## Recalls of this device
- Oct 18, 2013 · Class II · Z-0099-2015: Product has the potential to have a clear debris on the tip of the needle.

## Indications for use
the Crono Five and Crono PCA 50 has been designed for use in subcutaneous, intravenous, epidural and intrathecal infusions of prescribed liquid medicines.

Source page: https://510kreport.com/device/K052218
Methodology: https://510kreport.com/methodology