510(k) Report

FDA product code · Clinical chemistry

Cresolphthalein Complexone, Calcium

CICClass II21 CFR 862.1145510(k) required99 decisions since 19767 recalls

99 FDA decisions since 1976. 7 recalls name this code, 0 of them Class I. The most-cited predicate is K070249, named by 6 later devices.

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 CIC 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 · CIC

1in 2013

2007: 12009: 12013: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CIC

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

Recalls per year · CIC

1in 2016

2009: 32010: 22016: 1
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · CIC

10in 2025

2009: 52010: 832011: 292012: 102013: 42014: 12016: 302017: 62018: 422021: 12023: 42024: 82025: 10
2007high 83 (2010) · low 0 (2007)2025

MAUDE reports naming product code CIC, 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
20071—00
20080—00
20091—35
20100—283
20110—029
20120—010
20131—04
20140—01
20150—00
20160—130
20170—06
20180—042
20190—00
20200—00
20210—01
20220—00
20230—04
20240—08
20250—010
20260—0—
FIG. 1 — CIC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CIC? 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 862.1145.