510(k) Report

FDA product code · General and plastic surgery

Chisel, Mastoid

JYDClass I21 CFR 878.4800510(k) exempt1 decision since 19930 recalls

FDA lists JYD as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 878.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 1993. 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, general and plastic surgery panel

Twenty years of JYD 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 · JYD

FDA has decided no JYD device since 2007.

Median 510(k) review, days · JYD

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

Recalls per year · JYD

No recall names JYD since 2007.

Adverse event reports per year · JYD

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

Planning a device in JYD? 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 878.4800.