510(k) Report

510(k) · Cleared

Cleared

Sonicwave Sonic Plaque Remover

K012914510(k) TraditionalCleared Oct 1, 200132-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

Homedics, Inc. · JEQ Toothbrush, Powered

Cleared on Oct 1, 2001 as substantially equivalent to K921773 (Optiva Corp., 1992) after a 32-day review. Its family tree reaches back 1 generation to 1992.

Decided
Oct 1, 2001
Review
32 days
Class
Class I
Product code
JEQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K921773 (1992). No later device cites it as a predicate yet.

K921773 · TX Electric Toothbrush · Optiva Corp. · 19921990199219941996199820002002
K921773 · TX Electric Toothbrush · Optiva Corp. · 19920
  1. Root · 1 generation backK921773 TX Electric ToothbrushOptiva Corp. · 1992
  2. This deviceK012914 Sonicwave Sonic Plaque RemoverHomedics, Inc. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921773TX Electric ToothbrushOptiva Corp.1992—
0 (this device)K012914Sonicwave Sonic Plaque RemoverHomedics, Inc.2001—
FIG. 1 — Lineage of K012914, 1992–2001Source: FDA 510(k) summaries, read by 510(k) Report · 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), the FDA summary (predicates and indications), 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K921773TX Electric Toothbrush
Summary page 1
…ivalence Claim: The SonicWave™ Sonic Plaque Remover is substantially equivalent to the current versions of the following model: 1. Sonicare Model TX-1 Sonic Toothbrush. K921773 Substantial equivalence is claimed because manufacturing technology, operating principles, intended uses and safety standards ar…
Optiva Corp.1992—

Also cleared against K921773: 1 other device →

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.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K921773.

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—

What is it indicated for?

Operates at over 30,000 strokes per minute to help remove plaque bacteria

Sonic waves penetrate beyond the bristle tips, for superior cleaning.

Ergonomic design with rubberized Comfort-Grip surface.

Two-minute timer helps ensure dentist recommended brush time.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K921773

1 other device cites the same predicate.

  • K040416Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004

More from Homedics, Inc.

2 FDA decisions under this applicant name. See the company

  • K001860Paraspa Paraffin Bath, Paraspap Mini, Paraspa UltraHomedics, Inc. · 2000

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/K012914 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012914: Sonicwave Sonic Plaque Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012914

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026