510(k) Report

510(k) · Cleared

Cleared

Sonicare Advance Toothbrush, Model 4900

K040416510(k) TraditionalCleared Jul 2, 2004135-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

Philips Oral Healthcare, Inc. · JEQ Toothbrush, Powered

Cleared on Jul 2, 2004 as substantially equivalent to K921773 (Optiva Corp., 1992) and 1 other predicate after a 135-day review. Its family tree reaches back 1 generation to 1992. 7 later devices descend from it.

Decided
Jul 2, 2004
Review
135 days
Class
Class I
Product code
JEQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K921773 (1992). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2006: 2 descendants cleared2014: 1 descendant cleared2008: 1 descendant cleared2012: 1 descendant cleared2009: 1 descendant cleared2020: 1 descendant clearedK921773 · TX Electric Toothbrush · Optiva Corp. · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants K921773 · TX Electric Toothbrush · Optiva Corp. · 19920
  1. Root · 1 generation backK921773 TX Electric ToothbrushOptiva Corp. · 1992
  2. This deviceK040416 Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004
  3. Descendant · cites it directly · 3 of its ownK061351 Oral-B Sonic CompleteBraun GmbH · 2006
  4. Descendant · 2 generations on · 2 of its ownK073224 Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008
  5. Descendant · cites it directly · 2 of its ownK061199 Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006
  6. Descendant · 2 generations on · 1 of its ownK141018 Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive…Procter & Gamble Co. · 2014
  7. Descendant · 3 generations on · 0 of its ownK200881 Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble Company · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12009: 12012: 12014: 12020: 1
2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all
  • K061351Oral-B Sonic CompleteBraun GmbH · 2006 · cites it directly3descendants
  • K073224Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008 · 2 generations on2descendants
  • K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006 · cites it directly2descendants
  • K141018Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…Procter & Gamble Co. · 2014 · 2 generations on1descendant
  • K200881Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble Company · 2020 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K921773TX Electric ToothbrushOptiva Corp.1992—
0 (this device)K040416Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc.2004—
+1K061351Oral-B Sonic CompleteBraun GmbH2006—
+2K073224Oral-B Sub-Brand Manual ToothbrushProcter & Gamble2008—
+1K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH2006—
+2K141018Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power…Procter & Gamble Co.2014—
+3K200881Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble Company2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
200910
201210
201410
202010
FIG. 1 — Lineage of K040416, 1992–2020Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
…name: Toothbrush, powered Product code (classification): JEQ (Class 1, 21 C.F.R. § 872.6865) Legally Marketed Predicate Devices: TX Electric Toothbrush (K921773) Dental Air Force Home Dental Cleaning System (KOO 1493) Device Description and Technological Characteristics: Sonicare® Advance…
Optiva Corp.1992—
*K001493Dental Air Force Home Dental Cleaning System, Model NO. 0020001Air Force, Inc.2000—

Also cleared against K921773: 1 other device →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061351Oral-B Sonic CompleteBraun GmbH20063
K061199Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH20062

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K061351 (Braun GmbH, 2006) has gone furthest, with 3 descendants of its own.
  • 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?

For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis.

Indications for use as stated in the FDA summary.

Also cleared against K921773

1 other device cites the same predicate.

  • K012914Sonicwave Sonic Plaque RemoverHomedics, Inc. · 2001

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
  • K022900Butler Gum Vari-Clean Power ToothbrushesJohn O. Butler Co. · 2002

https://510kreport.com/device/K040416 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040416: Sonicare Advance Toothbrush, Model 4900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040416

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026