510(k) Report

FDA product code · Hematology

Heparin

IAZClass I21 CFR 864.4400510(k) exempt0 decisions0 recalls

FDA lists IAZ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. 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, hematology panel

Twenty years of IAZ 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 · IAZ

FDA has decided no IAZ device since 2007.

Median 510(k) review, days · IAZ

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

Recalls per year · IAZ

No recall names IAZ since 2007.

Adverse event reports per year · IAZ

No MAUDE report names IAZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
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 — IAZ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in IAZ? 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 864.4400.

IBD HyaluronidaseIBF PapainIBG TrypsinLIJ Peroxidase Anti-Peroxidase Immunohistochemical…IBC DiastaseIBA Streptolysin OIBE Neuramininase (Sialidase)