510(k) Report

FDA product code · Clinical chemistry

Photometric Method, Ammonia

JIDClass I21 CFR 862.1065510(k) required4 decisions since 19811 recall

4 FDA decisions since 1981. 1 recall names this code; it is not Class I. The most-cited predicate is K820723, named by 1 later device.

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 JID 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 · JID

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JID

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

Recalls per year · JID

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 · JID

6in 2025

2008: 42009: 62010: 42011: 152012: 32013: 182014: 92015: 402016: 102017: 82018: 62019: 132020: 262021: 192022: 122023: 262024: 52025: 6
2007high 40 (2015) · low 0 (2007)2025

MAUDE reports naming product code JID, 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—04
20090—06
20100—04
20110—015
20120—03
20130—118
20140—09
20150—040
20160—010
20170—08
20180—06
20190—013
20200—026
20210—019
20220—012
20230—026
20240—05
20250—06
20261—0—
FIG. 1 — JID by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JID? 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 862.1065.