510(k) Report

FDA product code · Immunology

Fc, Fitc, Antigen, Antiserum, Control

DBKClass I21 CFR 866.5530510(k) exempt0 decisions0 recalls

FDA lists DBK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 866.9 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, immunology panel

Twenty years of DBK 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 · DBK

FDA has decided no DBK device since 2007.

Median 510(k) review, days · DBK

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

Recalls per year · DBK

No recall names DBK since 2007.

Adverse event reports per year · DBK

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

Planning a device in DBK? 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 866.5530.

DAS Igg (Fc Fragment Specific), Antigen…DBH Fc, Rhodamine, Antigen, Antiserum, ControlKTO Reagent, Immunoassay, IggDBN Fc, Antigen, Antiserum, Control