FDA product code · Hematology

Hemoglobin A2 Quantitation

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

JPDClass II21 CFR 864.7400510(k) required13 decisions since 19803 recalls

13 FDA decisions since 1980. 3 recalls name this code, 0 of them Class I. The most-cited predicate is K991127, named by 3 later devices.

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 JPD 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 · JPD

FDA has decided no JPD device since 2007.

Median 510(k) review, days · JPD

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

Recalls per year · JPD

1in 2011

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JPD

No MAUDE report names JPD since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	2	0
2009	—	0	0
2010	—	0	0
2011	—	1	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	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 — JPD by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JPD? 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

Hemoglobin A2 Quantitation

Which predicates do JPD devices cite most?

Which JPD devices have the deepest lineage?

What has FDA decided in JPD lately?

What has been recalled in JPD lately?