510(k) Report

FDA product code · Hematology

Hematocrit, Tube, Rack, Sealer, Holder

GHYClass II21 CFR 864.6400510(k) exempt2 decisions since 19880 recalls

FDA lists GHY as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 2 FDA decisions since 1988. 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, hematology panel

Twenty years of GHY 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 · GHY

FDA has decided no GHY device since 2007.

Median 510(k) review, days · GHY

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

Recalls per year · GHY

No recall names GHY since 2007.

Adverse event reports per year · GHY

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

Planning a device in GHY? 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 GHY lately?

  • K883185Safecrit Plastic Microhematocrit TubesNorfolk Scientific, Inc. · 1988
  • K881186Microhematocrit Tubes, Heparin & Microhema Tube,PLHelps Products, Inc. · 1988

All 2 GHY decisions →

Related product codes

Other codes under 21 CFR 864.6400.

JPI Device, Hematocrit MeasuringGKG Centrifuge, Hematocrit