FDA product code · Hematology

Bothrops Atrox Reagent

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

JCOClass II21 CFR 864.8100510(k) required7 decisions since 19780 recalls

7 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, hematology panel

Twenty years of JCO 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 · JCO

FDA has decided no JCO device since 2007.

Median 510(k) review, days · JCO

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

Recalls per year · JCO

No recall names JCO since 2007.

Adverse event reports per year · JCO

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code JCO, 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	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

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

Planning a device in JCO? 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

Bothrops Atrox Reagent

What has FDA decided in JCO lately?