510(k) · Cleared
ClearedInvisalign® Palatal Expander System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Align Technology, Inc. · NXC Aligner, Sequential
Cleared on Oct 23, 2025 as substantially equivalent to K232887 (Align Technology, Inc., 2023) after a 38-day review. Its family tree reaches back 7 generations to 1978.
- Decided
- Oct 23, 2025
- Review
- 38 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K780619 (1978). 8 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 backK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- 2 generations backK220287 Invisalign SystemAlign Technology, Inc. · 2022 · Recalled
- 1 generation backK232887 Invisalign Palatal Expander SystemAlign Technology, Inc. · 2023
- This deviceK252931 Invisalign® Palatal Expander SystemAlign Technology, Inc. · 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 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| −2 | K220287 | Invisalign System | Align Technology, Inc. | 2022 | 1 |
| −1 | K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | 2023 | — |
| 0 (this device) | K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K232887 | Invisalign Palatal Expander SystemSummary page 5…5470 Product Code(s) NXC, PNN | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232887 Invisalign Palatal Expander System NXC, PNN K252380 Invisalign System NXC, PNN Device Description Summary 21 CFR 807.92(a)(4) Th… | 2023 |
| † | K252380 | Invisalign System | 2025 |
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 3 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
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 Invisalign® Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and teeth, palate) with primary, mixed, or permanent dentition and during orthodontic or orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.
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/K252931 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252931: Invisalign® Palatal Expander System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252931
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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