# K053257: Para-Pro FC50

- Pathway: 510(k) (Traditional)
- Applicant: Alpha-Tec Systems, Inc.
- Decided: May 12, 2006 after 171 days
- Product code: LKS (Device, Parasite Concentration)
- Device class: 1
- Regulation: 21 CFR 866.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Para-ProTM fc5O is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF Tm CLR) for the sodium acetate acetic acid formaldehyde; and Proto-fix for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.

Source page: https://510kreport.com/device/K053257
Methodology: https://510kreport.com/methodology