510(k) Report

FDA product code · Clinical chemistry

Radioimmunoassay, Total Triiodothyronine

CDPClass II21 CFR 862.1710510(k) exempt144 decisions since 197610 recalls

FDA lists CDP 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. 144 FDA decisions since 1976. 10 recalls name this code, 0 of them Class I. The most-cited predicate is K934517, 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 CDP 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 · CDP

FDA has decided no CDP device since 2007.

Median 510(k) review, days · CDP

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

Recalls per year · CDP

3in 2018

2013: 22014: 12015: 12017: 12018: 3
2007high 3 (2018) · low 0 (2007)2026

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

Adverse event reports per year · CDP

25in 2025

2010: 32011: 82012: 22013: 102014: 1112015: 1582016: 1502017: 1512018: 3652019: 3432020: 2092021: 1202022: 1232023: 1312024: 412025: 25
2007high 365 (2018) · low 0 (2007)2025

MAUDE reports naming product code CDP, 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—03
20110—08
20120—02
20130—210
20140—1111
20150—1158
20160—0150
20170—1151
20180—3365
20190—0343
20200—0209
20210—0120
20220—0123
20230—0131
20240—041
20250—025
20260—0—
FIG. 1 — CDP by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CDP? 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