510(k) · Cleared

Cleared

Propoxphene Eia Test

K943414510(k) TraditionalCleared Sep 9, 199456-day reviewClass II21 CFR 862.3700

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

Diagnostic Reagents, Inc. · JXN Enzyme Immunoassay, Propoxyphene

Cleared on Sep 9, 1994 after a 56-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided: Sep 9, 1994
Review: 56 days
Class: Class II
Product code: JXN
Recalls: None
Predicates: 0

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

This deviceK943414 Propoxphene Eia TestDiagnostic Reagents, Inc. · 1994
Descendant · cites it directly · 1 of its ownK023795 Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121…Lin-Zhi International, Inc. · 2003
Descendant · 2 generations on · 0 of its ownK033885 BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all

K023795Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)Lin-Zhi International, Inc. · 2003 · cites it directly1descendant
K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K943414	Propoxphene Eia Test	Diagnostic Reagents, Inc.	1994	—
+1	K023795	Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000…	Lin-Zhi International, Inc.	2003	—
+2	K033885	BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)	Lin-Zhi International, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0

FIG. 1 — Lineage of K943414, 1994–2004Source: 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 lists a 510(k) statement for it but has not posted the file, 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
K023795	Propoxyphene Enzyme Immunoassay, Catalog #0120 (500 Test Kit), #0121 (5000 Test Kit)	Lin-Zhi International, Inc.	2003	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, K023795 (Lin-Zhi International, Inc., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JXN devices

JXN Enzyme Immunoassay, Propoxyphene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JXN

1in 2015

2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXN

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

Recalls per year · JXN

1in 2010

2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXN

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code JXN, not matched to any one device; reports are not rates.

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	—	1	0
2009	0	—	0	0
2010	0	—	1	0
2011	1	—	0	0
2012	0	—	0	0
2013	1	—	0	0
2014	0	—	0	0
2015	1	—	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	1
2025	0	—	0	0
2026	0	—	0	—

https://510kreport.com/device/K943414 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943414: Propoxphene Eia Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943414

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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