510(k) Report

FDA product code · Clinical chemistry

Radioimmunoassay (Two-Site Solid Phase), Ferritin

JMGClass II21 CFR 866.5340510(k) required24 decisions since 19782 recalls

24 FDA decisions since 1978. 510(k) reviews decided 2021–2025 took a median of 90 days (half between 90 and 90). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K926221, named by 5 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 JMG 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 · JMG

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JMG

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

Recalls per year · JMG

1in 2025

2013: 12025: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JMG

12in 2025

2010: 12013: 122014: 22016: 12017: 12018: 32019: 12020: 42021: 52022: 22023: 132024: 112025: 12
2007high 13 (2023) · low 0 (2007)2025

MAUDE reports naming product code JMG, 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
20070—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—112
20140—02
20150—00
20160—01
20170—01
20180—03
20190—01
20200—04
20210—05
20220—02
20230—013
20241—011
20250—112
20260—0—
FIG. 1 — JMG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JMG? 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 866.5340.