FDA product code · Hematology

Hemoglobin M

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

JPBClass II21 CFR 864.7415510(k) required0 decisions2 recalls

0 FDA decisions. 2 recalls name this code, 0 of them Class I.

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 JPB 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 · JPB

FDA has decided no JPB device since 2007.

Median 510(k) review, days · JPB

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

Recalls per year · JPB

1in 2017

2007high 1 (2016) · low 0 (2007)2026

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

Adverse event reports per year · JPB

No MAUDE report names JPB since 2007.

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	—	1	0
2017	—	1	0
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

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

Planning a device in JPB? 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

Related product codes

Other codes under 21 CFR 864.7415.

JCM Control, Hemoglobin, Abnormal MLL Hemoglobin C (Abnormal Hemoglobin Variant)GIQ Hemoglobin S GKA Abnormal Hemoglobin Quantitation

Hemoglobin M

What has been recalled in JPB lately?

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