510(k) Report

510(k) · Cleared

Cleared

Hukuba Hyg Electric Ionic Toothbrush

K945248510(k) TraditionalCleared Jan 26, 199591-day reviewClass I21 CFR 872.6865

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Hukuba Dental Corp. · JEQ Toothbrush, Powered

Cleared on Jan 26, 1995 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 26, 1995
Review
91 days
Class
Class I
Product code
JEQ
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K945248Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JEQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JEQ device

  1. #1 K200881 Oral-B iO Test Drive Power Brush Trial Program…score 0.8 · 4 generations · no Class I recall
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JEQ devices

JEQ Toothbrush, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Hukuba Dental Corp.

2 FDA decisions under this applicant name. See the company

  • K915576Hubuka Hyg ToothbrushHukuba Dental Corp. · 1994

Recent decisions in JEQ

The JEQ category page

  • K200881Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble Company · 2020
  • K141018Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit, Oral-B Test Drive…Procter & Gamble Co. · 2014
  • K061351Oral-B Sonic CompleteBraun GmbH · 2006
  • K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006
  • K040416Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004

https://510kreport.com/device/K945248 · printed Nov 5, 2026

Cite this page

510(k) Report. “K945248: Hukuba Hyg Electric Ionic Toothbrush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945248

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026