FDA product code · Cardiovascular

Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

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

JODClass II21 CFR 870.4270510(k) required12 decisions since 19780 recalls

12 FDA decisions since 1978. No recall names this code. The most-cited predicate is K890504, named by 1 later device.

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, cardiovascular panel

Twenty years of JOD 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 · JOD

FDA has decided no JOD device since 2007.

Median 510(k) review, days · JOD

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

Recalls per year · JOD

No recall names JOD since 2007.

Adverse event reports per year · JOD

1in 2015

2007high 3 (2007) · low 0 (2009)2025

MAUDE reports naming product code JOD, 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	—	3
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	1
2013	—	0
2014	—	0
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JOD? 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

Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass

Which predicates do JOD devices cite most?

Which JOD devices have the deepest lineage?

What has FDA decided in JOD lately?