510(k) Report

FDA product code · Hematology

Fluid, Diluting, Manual Cell

JCGClass I21 CFR 864.8200510(k) exempt1 decision since 19890 recalls

FDA lists JCG 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. 1 FDA decision since 1989. 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 JCG 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 · JCG

FDA has decided no JCG device since 2007.

Median 510(k) review, days · JCG

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

Recalls per year · JCG

No recall names JCG since 2007.

Adverse event reports per year · JCG

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

Planning a device in JCG? 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 JCG lately?

  • K892658Sdi Prepax Countapette KitScientific Distributors, Inc. · 1989

The one JCG decision →

Related product codes

Other codes under 21 CFR 864.8200.

GGJ Fluid, Diluting, White-CellGIF Diluent, Blood CellGJN Fluid, Diluting, Red-Cell