FDA product code · Clinical chemistry

Fluorometric Measurement, Porphyrins

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

JKJClass I21 CFR 862.1595510(k) exempt3 decisions since 19780 recalls

FDA lists JKJ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 3 FDA decisions since 1978. No recall names this code.

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, clinical chemistry panel

Twenty years of JKJ 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 · JKJ

FDA has decided no JKJ device since 2007.

Median 510(k) review, days · JKJ

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

Recalls per year · JKJ

No recall names JKJ since 2007.

Adverse event reports per year · JKJ

1in 2019

2007high 1 (2019) · low 0 (2007)2025

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

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	—	1
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JKJ? 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

Fluorometric Measurement, Porphyrins

What has FDA decided in JKJ lately?