510(k) Report

FDA product code · Immunology

Complement C3b Activator Immunoassay Reagents

KTPClass II21 CFR 866.5260510(k) required1 decision since 19790 recalls

1 FDA decision 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, immunology panel

Twenty years of KTP 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 · KTP

FDA has decided no KTP device since 2007.

Median 510(k) review, days · KTP

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

Recalls per year · KTP

No recall names KTP since 2007.

Adverse event reports per year · KTP

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

Planning a device in KTP? 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 KTP lately?

  • K790059Proactivator C3, C4 and C3Icl Scientific · 1979

The one KTP decision →

Related product codes

Other codes under 21 CFR 866.5260.

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