FDA product code · Hematology

Test, Euglobulin Lysis

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

JBOClass II21 CFR 864.7275510(k) exempt1 decision since 19830 recalls

FDA lists JBO 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. 1 FDA decision since 1983. 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 JBO 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 · JBO

FDA has decided no JBO device since 2007.

Median 510(k) review, days · JBO

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

Recalls per year · JBO

No recall names JBO since 2007.

Adverse event reports per year · JBO

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

Planning a device in JBO? 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

Test, Euglobulin Lysis

What has FDA decided in JBO lately?