510(k) · Cleared
ClearedCleo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Orthodontics · NJM Bracket, Ceramic, Orthodontic
Cleared on Jul 7, 2023 as substantially equivalent to K122753 (American Orthodontics, 2012) and 1 other predicate after a 1-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Jul 7, 2023
- Review
- 1 day
- Class
- Class II
- Product code
- NJM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K852179 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK852179 Ceramic Orthodonit ApplianceGac Intl., Inc. · 1985
- 3 generations backK042178 Orthodontic Ceramic BracketsDentsply Intl. · 2004
- 2 generations backK060837 IN-Ovation CDentsply International · 2006
- 1 generation backK122753 Empower ClearAmerican Orthodontics · 2012
- This deviceK232011 CleoAmerican Orthodontics · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852179 | Ceramic Orthodonit Appliance | Gac Intl., Inc. | 1985 | — |
| −3 | K042178 | Orthodontic Ceramic Brackets | Dentsply Intl. | 2004 | — |
| −2 | K060837 | IN-Ovation C | Dentsply International | 2006 | — |
| −1 | K122753 | Empower Clear | American Orthodontics | 2012 | — |
| 0 (this device) | K232011 | Cleo | American Orthodontics | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 NJM? 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 NJM device
- #1 K222764 LightForce Orthodontic Systemscore 8.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122753 | Empower ClearSummary page 4…rmation: 1st Predicate Device Product/Trade Name: Empower Clear Classification Name: Bracket, Ceramic, Orthodontic 510(k) Number: K122753 Product Code: NJM Regulation Number (21CFR): 872.5470 2nd Predicate Device Product/Trade… | 2012 |
| * | K080749 | RadianceSummary page 4…FR): 872.5470 2nd Predicate Device Product/Trade Name: Radiance Classification Name: Bracket, Ceramic, Orthodontic 510(k) Number: K080749 Product Code: NJM Regulation Number (21CFR): 872.5470 Description of the Device: Device Design: The Cleo b… | 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 38 years and passes through 4 companies; a new generation was cleared every 10.6 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All NJM devicesNJM Bracket, Ceramic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NJM
5in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJM
1in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJM
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJM
1in 2025
MAUDE reports naming product code NJM, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 134 | 0 | 0 |
| 2009 | 4 | 61 | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 4 | 122 | 0 | 1 |
| 2012 | 6 | 90 | 0 | 1 |
| 2013 | 3 | 123 | 1 | 6 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 3 | 234 | 0 | 0 |
| 2016 | 3 | 176 | 0 | 2 |
| 2017 | 3 | 183 | 0 | 2 |
| 2018 | 4 | 76 | 0 | 2 |
| 2019 | 6 | 200 | 0 | 0 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 5 | 1 | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth.
The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnonnalities as diagnosed by a trained dental professional or orthodontist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232011 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232011: Cleo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232011
Report an extraction error
Are you the manufacturer?
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