510(k) · Cleared
ClearedSparkTM Clear Aligner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ormco Corporation · NXC Aligner, Sequential
Cleared on Feb 20, 2025 as substantially equivalent to K223517 (Wuxi EA Medical Instruments Technologies Limited., 2023) and 1 other predicate after a 1-day review. Its family tree reaches back 7 generations to 1978.
- Decided
- Feb 20, 2025
- Review
- 1 day
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K780619 (1978). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 6 generations backK981095 Align SystemAlign Technology · 1998
- 5 generations backK081960 Invisalign SystemAlign Technology · 2008
- 4 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 3 generations backK171674 Angel Align SystemSmile Development Corp · 2018
- 2 generations backK203688 Clear AlignerWuxi EA Medical Instruments Technologies Limited. · 2021
- 1 generation backK223517 Clear AlignerWuxi EA Medical Instruments Technologies Limited. · 2023
- This deviceK250487 SparkTM Clear Aligner SystemOrmco Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −6 | K981095 | Align System | Align Technology | 1998 | — |
| −5 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −4 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −3 | K171674 | Angel Align System | Smile Development Corp | 2018 | — |
| −2 | K203688 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. | 2021 | — |
| −1 | K223517 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. | 2023 | — |
| 0 (this device) | K250487 | SparkTM Clear Aligner System | Ormco Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K223517 | Clear AlignerSummary page 6…872.5470 Product Code(s) NXC | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223517 Clear Aligner NXC K240501 Spark™ Clear Aligner System NXC Device Description Summary 21 CFR 807.92(a)(4) The Spark™ Clear Aligne… | 2023 |
| * | K240501 | Spark™ Clear Aligner SystemSummary page 6…NXC | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K223517 Clear Aligner NXC K240501 Spark™ Clear Aligner System NXC Device Description Summary 21 CFR 807.92(a)(4) The Spark™ Clear Aligner System consists of a ser… | 2024 |
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 47 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250487: SparkTM Clear Aligner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250487
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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