510(k) Report

FDA product code · General and plastic surgery

Electrode, Electrosurgical

JOSClass II21 CFR 878.4400510(k) required36 decisions since 19779 recalls

36 FDA decisions since 1977. 9 recalls name this code, 0 of them Class I. The most-cited predicate is K903302, named by 4 later devices.

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 JOS 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 · JOS

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOS

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

Recalls per year · JOS

2in 2019

2008: 12012: 22016: 12019: 2
2007high 2 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOS

6in 2025

2007: 292008: 372009: 622010: 142011: 52012: 72013: 52014: 72015: 132016: 62017: 72018: 102019: 172020: 122021: 52022: 82023: 92024: 32025: 6
2007high 62 (2009) · low 3 (2024)2025

MAUDE reports naming product code JOS, 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—029
20080—137
20090—062
20100—014
20110—05
20120—27
20130—05
20140—07
20150—013
20161—16
20170—07
20180—010
20190—217
20200—012
20210—05
20220—08
20230—09
20240—03
20250—06
20260—0—
FIG. 1 — JOS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JOS? 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 878.4400.