FDA product code · Clinical chemistry

Flame Photometry, Potassium

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

JGMClass II21 CFR 862.1600510(k) required5 decisions since 19770 recalls

5 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, clinical chemistry panel

Twenty years of JGM 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 · JGM

FDA has decided no JGM device since 2007.

Median 510(k) review, days · JGM

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

Recalls per year · JGM

No recall names JGM since 2007.

Adverse event reports per year · JGM

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

Planning a device in JGM? 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 862.1600.

CEM Electrode, Ion Specific, Potassium CEJ Tetraphenyl Borate, Colorimetry, Potassium MZV Test, System, Potassium, Enzymatic Method

Flame Photometry, Potassium

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