FDA product code · Microbiology

Dna Probe, Trichomonas Vaginalis

Name: FDA decisions, review times, recalls and adverse event reports for product code MJK
Creator: 510(k) Report

MJKClass I21 CFR 866.2660510(k) exempt1 decision since 19926 recalls

FDA lists MJK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1992. 6 recalls name this code, 0 of them Class I.

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

FIG. A — Illustration, microbiology panel

Twenty years of MJK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MJK

FDA has decided no MJK device since 2007.

Median 510(k) review, days · MJK

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

Recalls per year · MJK

1in 2008

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · MJK

3in 2025

2007high 32 (2014) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	3	0
2008	—	1	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	3
2013	—	0	8
2014	—	0	32
2015	—	0	6
2016	—	0	2
2017	—	0	0
2018	—	0	3
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	6
2024	—	0	3
2025	—	0	3
2026	—	0	—

FIG. 1 — MJK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MJK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 866.2660.

NZS Fish (Fluorescent In Situ Hybridization) Kit…JSR Kit, Identification, Dermatophyte OMN C. Difficile Nucleic Acid Amplification Test…JXC Kit, Screening, Yeast JWZ Kit, Screening, Trichomonas JSZ Kit, Identification, Pseudomonas JSP Kit, Anaerobic Identification JST Kit, Fastidious Organisms JSY Kit, Identification, Mycobacteria LQL Gram Positive Identification Panel LQM Gram Negative Identification Panel MJM Dna Probe, Gardnerella Vaginalis

Dna Probe, Trichomonas Vaginalis

What has FDA decided in MJK lately?

What has been recalled in MJK lately?

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