510(k) · Cleared

Cleared

Psychemedics Ria Cocaine Assay

K010868510(k) TraditionalCleared Nov 6, 2001228-day reviewClass II21 CFR 862.3250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Psychemedics Corp. · KLN Radioimmunoassay, Cocaine Metabolite

Cleared on Nov 6, 2001 after a 228-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Nov 6, 2001
Review: 228 days
Class: Class II
Product code: KLN
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK010868 Psychemedics Ria Cocaine AssayPsychemedics Corp. · 2001
Descendant · cites it directly · 1 of its ownK111925 Psychemedics Cocaine EiaPsychemedics Corp. · 2012
Descendant · 2 generations on · 0 of its ownK201228 Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation · 2021

Most influential descendants

Showing 2 of 2 · See all

K111925Psychemedics Cocaine EiaPsychemedics Corp. · 2012 · cites it directly1descendant
K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010868	Psychemedics Ria Cocaine Assay	Psychemedics Corp.	2001	—
+1	K111925	Psychemedics Cocaine Eia	Psychemedics Corp.	2012	—
+2	K201228	Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair	Psychemedics Corporation	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2021	1	0

FIG. 1 — Lineage of K010868, 2001–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111925	Psychemedics Cocaine Eia	Psychemedics Corp.	2012	1

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.

What does this lineage say?

Of its descendants, K111925 (Psychemedics Corp., 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KLN devices

KLN Radioimmunoassay, Cocaine Metabolite: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLN

FDA has decided no KLN device since 2007.

Median 510(k) review, days · KLN

Too few KLN 510(k)s in any year since 2007 to give a median.

Recalls per year · KLN

No recall names KLN since 2007.

Adverse event reports per year · KLN

No MAUDE report names KLN since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K010868 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010868: Psychemedics Ria Cocaine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010868

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026