FDA product code · Hematology

Red-Cell Indices, Calculated

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

JPJClass II21 CFR 864.5300510(k) required3 decisions since 19770 recalls

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 JPJ 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 · JPJ

FDA has decided no JPJ device since 2007.

Median 510(k) review, days · JPJ

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

Recalls per year · JPJ

No recall names JPJ since 2007.

Adverse event reports per year · JPJ

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

Planning a device in JPJ? 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 864.5300.

JBW Red-Cell Indices, Measured KQH Red-Cell Indices

Red-Cell Indices, Calculated

What has FDA decided in JPJ lately?

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