# K021420: Paracon II/Fecal Concentrator II

- Pathway: 510(k) (Traditional)
- Applicant: Para Scientific Co.
- Decided: Jun 4, 2002 after 32 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
ParaCon II / Fecal Concentrator II is a filtration device that is intended for use in the separation of intestinal parasites from fecal debris in preserved fecal specimens. Fecal specimens that have been preserved in preservatives such as formalin, sodium acetate-acetic acid-formalin, merthiolate-formalin, or modified polyvinyl alcohol, and which are contained in 30 ml transport vials, may be added to the ParaCon II / Fecal Concentrator II filtration device and inverted in order to separate fecal debris from the specimen. The filtered specimen may then be concentrated by centrifugation, and observed microscopically.

Source page: https://510kreport.com/device/K021420
Methodology: https://510kreport.com/methodology