510(k) Report

FDA product code · General hospital

Scissors, Medical, Disposable

JOKClass I21 CFR 880.6820510(k) exempt7 decisions since 19770 recalls

FDA lists JOK as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 880.9 applies, such as a new intended use or a different fundamental technology. 7 FDA decisions since 1977. 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 hospital panel

Twenty years of JOK 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 · JOK

FDA has decided no JOK device since 2007.

Median 510(k) review, days · JOK

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

Recalls per year · JOK

No recall names JOK since 2007.

Adverse event reports per year · JOK

1in 2017

2009: 12017: 1
2007high 1 (2009) · low 0 (2007)2025

MAUDE reports naming product code JOK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — JOK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JOK? 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