510(k) · Cleared
ClearedThe Orthotrainer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myofunctional Research Corp. Pty., Ltd. · KMY Positioner, Tooth, Preformed
Cleared on Jul 8, 1993 after a 281-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jul 8, 1993
- Review
- 281 days
- Class
- Class I
- Product code
- KMY
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK924975 The OrthotrainerMyofunctional Research Corp. Pty., Ltd. · 1993
- Descendant · cites it directly · 6 of its ownK110661 AcceledentOrthoaccel Technologies, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK130643 Acceledent AuraOrthoaccel Technologies, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK143120 OrthoPulseBiolux Research, Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK153048 AcceleDent AuraOrthoaccel Technologies, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK230905 OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110661AcceledentOrthoaccel Technologies, Inc. · 2011 · cites it directly6descendants
- K130643Acceledent AuraOrthoaccel Technologies, Inc. · 2013 · 2 generations on5descendants
- K143120OrthoPulseBiolux Research, Ltd. · 2015 · 2 generations on4descendants
- K153048AcceleDent AuraOrthoaccel Technologies, Inc. · 2016 · 3 generations on2descendants
- K230905OrthoPulse 2.0E (OPi2E-100)Biolux Technology GmbH · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924975 | The Orthotrainer | Myofunctional Research Corp. Pty., Ltd. | 1993 | — |
| +1 | K110661 | Acceledent | Orthoaccel Technologies, Inc. | 2011 | — |
| +2 | K130643 | Acceledent Aura | Orthoaccel Technologies, Inc. | 2013 | — |
| +2 | K143120 | OrthoPulse | Biolux Research, Ltd. | 2015 | — |
| +3 | K153048 | AcceleDent Aura | Orthoaccel Technologies, Inc. | 2016 | — |
| +3 | K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KMY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110661 | Acceledent | 2011 | 6 |
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, K110661 (Orthoaccel Technologies, Inc., 2011) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KMY devicesKMY Positioner, Tooth, Preformed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMY
FDA has decided no KMY device since 2007.
Median 510(k) review, days · KMY
Too few KMY 510(k)s in any year since 2007 to give a median.
Recalls per year · KMY
No recall names KMY since 2007.
Adverse event reports per year · KMY
452in 2025
MAUDE reports naming product code KMY, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 71 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 376 |
| 2025 | 0 | — | 0 | 452 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K924975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K924975: The Orthotrainer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924975
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026