FDA product code · Hematology

Test, Heparin Neutralization

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

JBRClass II21 CFR 864.7525510(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 JBR 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 · JBR

FDA has decided no JBR device since 2007.

Median 510(k) review, days · JBR

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

Recalls per year · JBR

No recall names JBR since 2007.

Adverse event reports per year · JBR

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

Planning a device in JBR? 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 864.7525.

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Test, Heparin Neutralization

What has FDA decided in JBR lately?

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