510(k) Report

FDA product code · Hematology

Timer, Coagulation

JBTClass II21 CFR 864.5400510(k) exempt0 decisions0 recalls

FDA lists JBT 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. 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, hematology panel

Twenty years of JBT 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 · JBT

FDA has decided no JBT device since 2007.

Median 510(k) review, days · JBT

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

Recalls per year · JBT

No recall names JBT since 2007.

Adverse event reports per year · JBT

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

Planning a device in JBT? 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 864.5400.

GIE FibrometerGKP Instrument, Coagulation, AutomatedGKN Timer, Clot, AutomatedKQG Instrument, Coagulation