510(k) · Cleared
ClearedOral B Professionalcare Series, Oral B Advancepower Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braun GmbH · JEQ Toothbrush, Powered
Cleared on May 31, 2006 as substantially equivalent to K040416 (Philips Oral Healthcare, Inc., 2004) after a 33-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- May 31, 2006
- Review
- 33 days
- Class
- Class I
- Product code
- JEQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K921773 (1992). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK921773 TX Electric ToothbrushOptiva Corp. · 1992
- 1 generation backK040416 Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004
- This deviceK061199 Oral B Professionalcare Series, Oral B Advancepower SeriesBraun GmbH · 2006
- Descendant · cites it directly · 1 of its ownK141018 Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive…Procter & Gamble Co. · 2014
- Descendant · 2 generations on · 0 of its ownK200881 Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble Company · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921773 | TX Electric Toothbrush | Optiva Corp. | 1992 | — |
| −1 | K040416 | Sonicare Advance Toothbrush, Model 4900 | Philips Oral Healthcare, Inc. | 2004 | — |
| 0 (this device) | K061199 | Oral B Professionalcare Series, Oral B Advancepower Series | Braun GmbH | 2006 | — |
| +1 | K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power… | Procter & Gamble Co. | 2014 | — |
| +2 | K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | The Procter & Gamble Company | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
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 K200881 Oral-B iO Test Drive Power Brush Trial Program…score 0.8 · 4 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040416 | Sonicare Advance Toothbrush, Model 4900Summary page 1…Toothbrush, Powered Product code (classification): JEQ (Class 1,21 C.F.R. 872.6865) Legally Marketed Predicate Devices: * Sonicare® Advance Toothbrush (K040416) Philips Oral Healthcare, Inc. * Oral-B® ProfessionalCare TM Series/Oral-B® AdvancePowerrTMSeries Braun… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit… | 2014 | 1 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K141018 (Procter & Gamble Co., 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K040416.
How does its category compare?
All JEQ devicesJEQ Toothbrush, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEQ
1in 2020
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEQ
485in 2025
MAUDE reports naming product code JEQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 4 | 67 |
| 2012 | 0 | — | 0 | 219 |
| 2013 | 0 | — | 2 | 122 |
| 2014 | 1 | — | 0 | 125 |
| 2015 | 0 | — | 0 | 505 |
| 2016 | 0 | — | 0 | 517 |
| 2017 | 0 | — | 0 | 868 |
| 2018 | 0 | — | 0 | 743 |
| 2019 | 0 | — | 0 | 385 |
| 2020 | 1 | — | 0 | 433 |
| 2021 | 0 | — | 0 | 548 |
| 2022 | 0 | — | 0 | 330 |
| 2023 | 0 | — | 0 | 555 |
| 2024 | 0 | — | 0 | 577 |
| 2025 | 0 | — | 0 | 485 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
To promote good oral hygiene including plaque removal and treating
and preventing gingivitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061199: Oral B Professionalcare Series, Oral B Advancepower Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061199
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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