510(k) · Cleared
ClearedBeam Brush/Beam App
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beam Technologies, LLC · EFW Toothbrush, Manual
Cleared on Jun 21, 2012 as substantially equivalent to K073224 (Procter & Gamble, 2008) after a 65-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Jun 21, 2012
- Review
- 65 days
- Class
- Class I
- Product code
- EFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921773 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK921773 TX Electric ToothbrushOptiva Corp. · 1992
- 3 generations backK040416 Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004
- 2 generations backK061351 Oral-B Sonic CompleteBraun GmbH · 2006
- 1 generation backK073224 Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008
- This deviceK121165 Beam Brush/Beam AppBeam Technologies, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921773 | TX Electric Toothbrush | Optiva Corp. | 1992 | — |
| −3 | K040416 | Sonicare Advance Toothbrush, Model 4900 | Philips Oral Healthcare, Inc. | 2004 | — |
| −2 | K061351 | Oral-B Sonic Complete | Braun GmbH | 2006 | — |
| −1 | K073224 | Oral-B Sub-Brand Manual Toothbrush | Procter & Gamble | 2008 | — |
| 0 (this device) | K121165 | Beam Brush/Beam App | Beam Technologies, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 EFW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K073224 | Oral-B Sub-Brand Manual ToothbrushSummary page 1…Toothbrush, Manual Product code (Classification): EFW (Class 1,21 CFR 872.6855) Legally Marketed Predicate Device: Oral-B0 "sub-brand" manual toothbrush (K073224) (i.e. CrossAction, Advantage, Pulsar, Pro-Health)… | 2008 |
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?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K073224.
How does its category compare?
All EFW devicesEFW Toothbrush, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EFW
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · EFW
Too few EFW 510(k)s in any year since 2007 to give a median.
Recalls per year · EFW
No recall names EFW since 2007.
Adverse event reports per year · EFW
71in 2025
MAUDE reports naming product code EFW, 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 | 6 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 145 |
| 2013 | 1 | — | 0 | 60 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 0 | — | 0 | 48 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 0 | 68 |
| 2018 | 0 | — | 0 | 109 |
| 2019 | 0 | — | 0 | 115 |
| 2020 | 0 | — | 0 | 113 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 327 |
| 2023 | 0 | — | 0 | 99 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 0 | — | 0 | 71 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Beam Brush is a toothbrush to remove plaque and debris from its user's teeth and aide in the prevention of tooth decay. The Beam Brush collects brushing usage data and wirelessly transmits the data to a software application (Beam App) that runs on the user's own mobile device ("smartphone").
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121165 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121165: Beam Brush/Beam App.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121165
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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