510(k) Report

FDA product code · Clinical chemistry

Vanillin Pyruvate, Ast/Sgot

CIFClass II21 CFR 862.1100510(k) exempt1 decision since 19830 recalls

FDA lists CIF 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 1983. 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 CIF 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 · CIF

FDA has decided no CIF device since 2007.

Median 510(k) review, days · CIF

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

Recalls per year · CIF

No recall names CIF since 2007.

Adverse event reports per year · CIF

1in 2011

2008: 12011: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code CIF, 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—01
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — CIF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in CIF? 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 862.1100.