510(k) Report

FDA product code · Clinical chemistry

Photometric Method, Magnesium

JGJClass I21 CFR 862.1495510(k) required90 decisions since 197711 recalls

90 FDA decisions since 1977. 11 recalls name this code, 0 of them Class I. The most-cited predicate is K861386, named by 2 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, clinical chemistry panel

Twenty years of JGJ 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 · JGJ

2in 2018

2007: 12009: 22011: 12012: 12017: 22018: 2
2007high 2 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JGJ

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

Recalls per year · JGJ

1in 2024

2012: 12013: 12015: 12016: 12019: 12020: 22021: 12022: 12024: 1
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JGJ

22in 2025

2008: 12009: 42010: 42011: 132012: 222013: 262014: 42015: 242016: 42017: 182018: 212019: 312020: 342021: 332022: 422023: 312024: 172025: 22
2007high 42 (2022) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—01
20092—04
20100—04
20111—013
20121—122
20130—126
20140—04
20150—124
20160—14
20172—018
20182—021
20190—131
20200—234
20210—133
20220—142
20230—031
20240—117
20250—022
20260—0—
FIG. 1 — JGJ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JGJ? 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 862.1495.