FDA product code · Hematology

Study, Platelet Adhesive

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

JBZClass II21 CFR 864.6650510(k) exempt3 decisions since 19770 recalls

FDA lists JBZ 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. 3 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, hematology panel

Twenty years of JBZ 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 · JBZ

FDA has decided no JBZ device since 2007.

Median 510(k) review, days · JBZ

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

Recalls per year · JBZ

No recall names JBZ since 2007.

Adverse event reports per year · JBZ

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

Planning a device in JBZ? 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

Study, Platelet Adhesive

What has FDA decided in JBZ lately?