FDA product code · Clinical chemistry

Refractometer For Clinical Use

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

JREClass I21 CFR 862.2800510(k) exempt13 decisions since 19790 recalls

FDA lists JRE as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 13 FDA decisions since 1979. 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, clinical chemistry panel

Twenty years of JRE 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 · JRE

FDA has decided no JRE device since 2007.

Median 510(k) review, days · JRE

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

Recalls per year · JRE

No recall names JRE since 2007.

Adverse event reports per year · JRE

2in 2019

2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code JRE, 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	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	2
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

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

Planning a device in JRE? 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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