FDA product code · Clinical chemistry

Oncometer, Plasma, For Clinical Use

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

JJKClass I21 CFR 862.2720510(k) exempt4 decisions since 19770 recalls

FDA lists JJK 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. 4 FDA decisions since 1977. 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 JJK 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 · JJK

FDA has decided no JJK device since 2007.

Median 510(k) review, days · JJK

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

Recalls per year · JJK

No recall names JJK since 2007.

Adverse event reports per year · JJK

No MAUDE report names JJK 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	—	—

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

Planning a device in JJK? 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

Oncometer, Plasma, For Clinical Use

What has FDA decided in JJK lately?