FDA product code · Hematology

Antithrombin Iii, Two Stage Clotting Time Assay

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

JPEClass II21 CFR 864.7060510(k) required1 decision since 19940 recalls

1 FDA decision since 1994. No recall names this code. The most-cited predicate is K933125, 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 JPE 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 · JPE

FDA has decided no JPE device since 2007.

Median 510(k) review, days · JPE

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

Recalls per year · JPE

No recall names JPE since 2007.

Adverse event reports per year · JPE

2in 2024

2007high 2 (2024) · low 0 (2007)2025

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

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	—	1
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	2
2025	—	0
2026	—	—

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

Planning a device in JPE? 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 864.7060.

JBQ Antithrombin Iii Quantitation DDQ Antigen, Antiserum, Control, Antithrombin Iii

Antithrombin Iii, Two Stage Clotting Time Assay

Which predicates do JPE devices cite most?

What has FDA decided in JPE lately?

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