# K042085: Crono F

- Pathway: 510(k) (Special)
- Applicant: Cane S.R.L.
- Decided: Sep 17, 2004 after 45 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: 2 generations back to K982838 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013855: Microjet Crono H, Cane S.R.I. (2002) Summary page 1.

## 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 F ambulatory infusion pump device have been designed for use in subcutaneous and intravenous infusion of prescribed liquid medicines.

Source page: https://510kreport.com/device/K042085
Methodology: https://510kreport.com/methodology