510(k) Report

FDA product code · Pathology

Igg, Peroxidase, Antigen, Antiserum, Control

DAAClass II21 CFR 866.5510510(k) required5 decisions since 19790 recalls

5 FDA decisions since 1979. 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, pathology panel

Twenty years of DAA 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 · DAA

FDA has decided no DAA device since 2007.

Median 510(k) review, days · DAA

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

Recalls per year · DAA

No recall names DAA since 2007.

Adverse event reports per year · DAA

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code DAA, 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—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—01
20250—00
20260—0—
FIG. 1 — DAA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DAA? 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 866.5510.