510(k) · Cleared
ClearedRed, White & Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allesee Orthodontic Appliances · NXC Aligner, Sequential
Cleared on Jun 18, 2004 after a 77-day review. The FDA summary names its predicate without a number. 68 later devices descend from it.
- Decided
- Jun 18, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 2 citing it directly.
- This deviceK040874 Red, White & BlueAllesee Orthodontic Appliances · 2004
- Descendant · cites it directly · 67 of its ownK071970 Clear Image AlignerSpecialty Appliance Works, Inc. · 2007
- Descendant · 2 generations on · 64 of its ownK082556 ClearcorrectClearcorrect, Inc. · 2009
- Descendant · 3 generations on · 60 of its ownK113618 Clearcorrect SystemClearcorrect, Inc. · 2012
- Descendant · 4 generations on · 15 of its ownK180241 Orthocaps TwinalignerOrtho Caps GmbH · 2018
- Descendant · 4 generations on · 13 of its ownK163689 3M Clear Tray Aligner3M Unitek Corporation · 2017
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K071970Clear Image AlignerSpecialty Appliance Works, Inc. · 2007 · cites it directly67descendants
- K082556ClearcorrectClearcorrect, Inc. · 2009 · 2 generations on64descendants
- K113618Clearcorrect SystemClearcorrect, Inc. · 2012 · 3 generations on60descendants
- K180241Orthocaps TwinalignerOrtho Caps GmbH · 2018 · 4 generations on15descendants
- K1636893M Clear Tray Aligner3M Unitek Corporation · 2017 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040874 | Red, White & Blue | Allesee Orthodontic Appliances | 2004 | — |
| +1 | K071970 | Clear Image Aligner | Specialty Appliance Works, Inc. | 2007 | — |
| +2 | K082556 | Clearcorrect | Clearcorrect, Inc. | 2009 | — |
| +3 | K113618 | Clearcorrect System | Clearcorrect, Inc. | 2012 | — |
| +4 | K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | 2018 | — |
| +4 | K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 7 | 0 |
| 2019 | 12 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Align Technology, Invisalign Named without a submission number |
What descends from it? (68)
See all 682 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?
- Of its descendants, K071970 (Specialty Appliance Works, Inc., 2007) has gone furthest, with 67 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.
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?
Red, White & Blue is a series of three, clear, lightwelght, plastic retainers intended to be used to correct minor to intermediate anterior tooth mal-alignments in patients with permanent dentition (second molars) by moving teeth progressively to a final, treated state,
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/K040874 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040874: Red, White & Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040874
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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