510(k) Report

FDA product code · Dental

Toothbrush, Powered

JEQClass I21 CFR 872.6865510(k) exempt54 decisions since 197729 recalls

FDA lists JEQ as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 872.9 applies, such as a new intended use or a different fundamental technology. 54 FDA decisions since 1977. 29 recalls name this code, 0 of them Class I. The most-cited predicate is K921773, named by 2 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, dental panel

Twenty years of JEQ 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 · JEQ

1in 2020

2014: 12020: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEQ

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

Recalls per year · JEQ

2in 2013

2011: 42013: 22026 (partial year): 2
2007high 4 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JEQ

485in 2025

2007: 52008: 102009: 122010: 122011: 672012: 2192013: 1222014: 1252015: 5052016: 5172017: 8682018: 7432019: 3852020: 4332021: 5482022: 3302023: 5552024: 5772025: 485
2007high 868 (2017) · low 5 (2007)2025

MAUDE reports naming product code JEQ, 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—05
20080—010
20090—012
20100—012
20110—467
20120—0219
20130—2122
20141—0125
20150—0505
20160—0517
20170—0868
20180—0743
20190—0385
20201—0433
20210—0548
20220—0330
20230—0555
20240—0577
20250—0485
20260—2—
FIG. 1 — JEQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JEQ? 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 872.6865.