510(k) Report

FDA product code · Immunology

Complement C3b Activator, Antigen, Antiserum, Control

DACClass II21 CFR 866.5260510(k) required2 decisions since 19770 recalls

2 FDA decisions since 1977. 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, immunology panel

Twenty years of DAC 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 · DAC

FDA has decided no DAC device since 2007.

Median 510(k) review, days · DAC

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

Recalls per year · DAC

No recall names DAC since 2007.

Adverse event reports per year · DAC

No MAUDE report names DAC 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 — DAC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in DAC? 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

What has FDA decided in DAC lately?

  • K891904EZ Complement C1Diamedix Corp. · 1989
  • K771583Fluorescent Anti. Anti-Human C3Burroughs Wellcome Co. · 1977

All 2 DAC decisions →

Related product codes

Other codes under 21 CFR 866.5260.

KTP Complement C3b Activator Immunoassay Reagents