510(k) Report

FDA product code · Clinical toxicology

Flame Photometry, Lithium

JIHClass II21 CFR 862.3560510(k) required12 decisions since 19771 recall

12 FDA decisions since 1977. 1 recall names this code; it is not Class I. The most-cited predicate is K011033, 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 toxicology panel

Twenty years of JIH 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 · JIH

FDA has decided no JIH device since 2007.

Median 510(k) review, days · JIH

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

Recalls per year · JIH

1in 2013

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

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

Adverse event reports per year · JIH

5in 2025

2011: 12012: 22013: 22014: 12018: 22021: 12024: 12025: 5
2007high 5 (2025) · low 0 (2007)2025

MAUDE reports naming product code JIH, 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—00
20110—01
20120—02
20130—12
20140—01
20150—00
20160—00
20170—00
20180—02
20190—00
20200—00
20210—01
20220—00
20230—00
20240—01
20250—05
20260—0—
FIG. 1 — JIH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JIH? 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 862.3560.