FDA product code · Hematology

Fibrin Monomer Paracoagulation

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

JBNClass II21 CFR 864.7300510(k) exempt2 decisions since 19780 recalls

FDA lists JBN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 2 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 JBN 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 · JBN

FDA has decided no JBN device since 2007.

Median 510(k) review, days · JBN

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

Recalls per year · JBN

No recall names JBN since 2007.

Adverse event reports per year · JBN

No MAUDE report names JBN 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 — JBN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JBN? 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

Fibrin Monomer Paracoagulation

What has FDA decided in JBN lately?