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 Dec 15, 2023 as substantially equivalent to K220287 (Align Technology, Inc., 2022) and 1 other predicate after an 88-day review. Its family tree reaches back 6 generations to 1978. 1 later device descends from it.
- Decided
- Dec 15, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K780619 (1978). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 5 generations backK981095 Align SystemAlign Technology · 1998
- 4 generations backK081960 Invisalign SystemAlign Technology · 2008
- 3 generations backK143630 Invisalign SystemAlign Technology, Inc. · 2015
- 2 generations backK181739 Invisalign System with Mandibular Advancement FeatureAlign Technology, Inc. · 2018
- 1 generation backK220287 Invisalign SystemAlign Technology, Inc. · 2022 · Recalled
- This deviceK232887 Invisalign Palatal Expander SystemAlign Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK252931 Invisalign® Palatal Expander SystemAlign Technology, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252931Invisalign® Palatal Expander SystemAlign Technology, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −5 | K981095 | Align System | Align Technology | 1998 | — |
| −4 | K081960 | Invisalign System | Align Technology | 2008 | — |
| −3 | K143630 | Invisalign System | Align Technology, Inc. | 2015 | — |
| −2 | K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018 | — |
| −1 | K220287 | Invisalign System | Align Technology, Inc. | 2022 | 1 |
| 0 (this device) | K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K220287 | Invisalign SystemSummary page 7…E) System (hereafter referred to as the IPE System) is a modification to the legally marketed multiple predicate devices, Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secon… | 2022 |
| * | K935154 | Dentaurum Expansion ScrewsSummary page 7…, Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secondary. The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252931 | Invisalign® Palatal Expander System | 2025 | 0 |
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 45 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K252931 (Align Technology, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K220287.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 tooth, palate) with primary, mixed, or permanent dentition 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 as stated in the FDA summary.
https://510kreport.com/device/K232887 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232887: Invisalign Palatal Expander System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232887
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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