510(k) · Cleared
ClearedClearpath Aligner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qserve America, Inc. · NXC Aligner, Sequential
Cleared on Nov 1, 2013 as substantially equivalent to K073121 (Nubrace, Inc., 2009) and 1 other predicate after a 352-day review. Its family tree reaches back 3 generations to 1978. 6 later devices descend from it.
- Decided
- Nov 1, 2013
- Review
- 352 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K780619 (1978). 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 2 generations backK981095 Align SystemAlign Technology · 1998
- 1 generation backK073121 Nubrace Invisible Removable OrthodonticsNubrace, Inc. · 2009
- This deviceK123514 Clearpath AlignerQserve America, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK162609 ClearPath AlignerClearpath Orthodontics, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK202857 ClearPath AlignerClearpath Orthodontics, Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK221097 SmileSeriesOrdont Orthodontic Laboratories, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK241137 Clear Moves AlignerClear Moves Aligners · 2024
- Descendant · 3 generations on · 0 of its ownK211537 QuickAlignersOral Image, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K162609ClearPath AlignerClearpath Orthodontics, Ltd. · 2017 · cites it directly4descendants
- K202857ClearPath AlignerClearpath Orthodontics, Ltd. · 2021 · 2 generations on3descendants
- K221097SmileSeriesOrdont Orthodontic Laboratories, Inc. · 2022 · 3 generations on1descendant
- K241137Clear Moves AlignerClear Moves Aligners · 2024 · 4 generations on0descendants
- K211537QuickAlignersOral Image, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −2 | K981095 | Align System | Align Technology | 1998 | — |
| −1 | K073121 | Nubrace Invisible Removable Orthodontics | Nubrace, Inc. | 2009 | — |
| 0 (this device) | K123514 | Clearpath Aligner | Qserve America, Inc. | 2013 | — |
| +1 | K162609 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | 2017 | — |
| +2 | K202857 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | 2021 | — |
| +3 | K221097 | SmileSeries | Ordont Orthodontic Laboratories, Inc. | 2022 | — |
| +4 | K241137 | Clear Moves Aligner | Clear Moves Aligners | 2024 | — |
| +3 | K211537 | QuickAligners | Oral Image, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 NXC? 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 NXC device
- #1 K220287 Invisalign Systemscore 20.3 · 5 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 |
|---|---|---|---|
| * | K073121 | Nubrace Invisible Removable OrthodonticsSummary page 1…21 CFR 872.5470UI NOV 0 12013 Product Code: NXC Predicate Devices: K073121 - NuBrace Invisible Removable Orthodontics (IRO), NuBrace, Inc. K9810… | 2009 |
| * | K981095 | Align SystemSummary page 1…NXC Predicate Devices: K073121 - NuBrace Invisible Removable Orthodontics (IRO), NuBrace, Inc. K981095 - Align System, Align Technology Inc. Statement of The ClearPath Aligner is a series of clear, lightweight, plastic… | 1998 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 35 years and passes through 4 companies; a new generation was cleared every 10.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162609 (Clearpath Orthodontics, Ltd., 2017) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NXC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXC
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXC
4,523in 2025
MAUDE reports naming product code NXC, 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 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 59 |
| 2012 | 2 | — | 0 | 24 |
| 2013 | 4 | 124 | 0 | 28 |
| 2014 | 0 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 43 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 3 | 85 | 0 | 47 |
| 2018 | 11 | 116 | 0 | 67 |
| 2019 | 16 | 182 | 0 | 127 |
| 2020 | 16 | 230 | 0 | 175 |
| 2021 | 20 | 97 | 0 | 929 |
| 2022 | 19 | 137 | 0 | 605 |
| 2023 | 13 | 152 | 0 | 433 |
| 2024 | 14 | 105 | 2 | 8,991 |
| 2025 | 11 | 61 | 0 | 4,523 |
| 2026 | 5 | 127 | 0 | — |
What is it indicated for?
The ClearPath Aligner Is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentitian (i.e. all second molars). The ClearPath Aligner is intended for minor anterior tooth movement by way of continuous gentle force.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123514: Clearpath Aligner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123514
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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