FDA product code · Hematology

System, Analysis, Electrophoretic Hemoglobin

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

JBDClass II21 CFR 864.7440510(k) required26 decisions since 19773 recalls

26 FDA decisions since 1977. 3 recalls name this code, 0 of them Class I. The most-cited predicate is K802821, 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, hematology panel

Twenty years of JBD 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 · JBD

FDA has decided no JBD device since 2007.

Median 510(k) review, days · JBD

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

Recalls per year · JBD

1in 2018

2007high 1 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JBD

2in 2019

2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code JBD, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	1	0
2019	—	0	2
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in JBD? 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

System, Analysis, Electrophoretic Hemoglobin

Which predicates do JBD devices cite most?

What has FDA decided in JBD lately?

What has been recalled in JBD lately?