FDA product code · Clinical chemistry

5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

Name: FDA decisions, review times, recalls and adverse event reports for product code CED
Creator: 510(k) Report

CEDClass I21 CFR 862.1520510(k) exempt9 decisions since 19790 recalls

FDA lists CED as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 862.9 applies, such as a new intended use or a different fundamental technology. 9 FDA decisions since 1979. No recall names this code.

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 CED 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 · CED

FDA has decided no CED device since 2007.

Median 510(k) review, days · CED

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

Recalls per year · CED

No recall names CED since 2007.

Adverse event reports per year · CED

No MAUDE report names CED since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — CED by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CED? 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

5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

What has FDA decided in CED lately?