FDA product code · Hematology

Hemoglobin F Quantitation

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

JPCClass II21 CFR 864.7455510(k) required1 decision since 19820 recalls

1 FDA decision since 1982. 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 JPC 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 · JPC

FDA has decided no JPC device since 2007.

Median 510(k) review, days · JPC

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

Recalls per year · JPC

No recall names JPC since 2007.

Adverse event reports per year · JPC

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

Planning a device in JPC? 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

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Other codes under 21 CFR 864.7455.

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Hemoglobin F Quantitation

What has FDA decided in JPC lately?

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