510(k) Report

FDA product code · Clinical chemistry

Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes

CJOClass II21 CFR 862.1050510(k) required4 decisions since 19771 recall

4 FDA decisions since 1977. 1 recall names this code; it is not Class I.

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 CJO 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 · CJO

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CJO

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

Recalls per year · CJO

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · CJO

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code CJO, 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
20122—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—10
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — CJO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CJO? 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 862.1050.