510(k) · Cleared
ClearedParacon II/Fecal Concentrator II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Para Scientific Co. · LKS Device, Parasite Concentration
Cleared on Jun 4, 2002 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 4, 2002
- Review
- 32 days
- Class
- Class I
- Product code
- LKS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LKS devicesLKS Device, Parasite Concentration: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKS
FDA has decided no LKS device since 2007.
Median 510(k) review, days · LKS
Too few LKS 510(k)s in any year since 2007 to give a median.
Recalls per year · LKS
No recall names LKS since 2007.
Adverse event reports per year · LKS
No MAUDE report names LKS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021420 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021420: Paracon II/Fecal Concentrator II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021420
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026