FDA product code · Clinical chemistry

Radioimmunoassay, Androsterone

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

CIYClass I21 CFR 862.1080510(k) exempt1 decision since 19770 recalls

FDA lists CIY 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. 1 FDA decision since 1977. 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 CIY 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 · CIY

FDA has decided no CIY device since 2007.

Median 510(k) review, days · CIY

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

Recalls per year · CIY

No recall names CIY since 2007.

Adverse event reports per year · CIY

No MAUDE report names CIY 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 — CIY by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CIY? 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

Radioimmunoassay, Androsterone

What has FDA decided in CIY lately?