510(k) Report

FDA product code · Immunology

Ng4m (A), Antigen, Antiserum, Control

DHYClass I21 CFR 866.5065510(k) exempt1 decision since 19810 recalls

FDA lists DHY 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. 1 FDA decision since 1981. 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 DHY 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 · DHY

FDA has decided no DHY device since 2007.

Median 510(k) review, days · DHY

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

Recalls per year · DHY

No recall names DHY since 2007.

Adverse event reports per year · DHY

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

Planning a device in DHY? 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 DHY lately?

  • K810871Lightning DialyzerClintox Laboratories, Inc. · 1981

The one DHY decision →

Related product codes

Other codes under 21 CFR 866.5065.

DHQ Ng3m (G), Antigen, Antiserum, ControlDHI Ng3m (Bo), Antigen, Antiserum, ControlDGX Ng1m (A), Antigen, Antiserum, ControlDHF D/Km-1, Antigen, Antiserum, Control