510(k) · Cleared
ClearedMyotrac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thought Technology, Ltd. · HCC Device, Biofeedback
Cleared on Sep 26, 1988 after a 175-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Sep 26, 1988
- Review
- 175 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK881416 MyotracThought Technology, Ltd. · 1988
- Descendant · cites it directly · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- Descendant · 2 generations on · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
- Descendant · 2 generations on · 0 of its ownK214037 Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK222912 c1TracZimmer Medizinsysteme GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK150695 ModpodHollywog, LLC · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · cites it directly8descendants
- K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · 2 generations on1descendant
- K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024 · 2 generations on0descendants
- K222912c1TracZimmer Medizinsysteme GmbH · 2023 · 3 generations on0descendants
- K150695ModpodHollywog, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881416 | Myotrac | Thought Technology, Ltd. | 1988 | — |
| +1 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| +2 | K151640 | Eltrac 471 | Enraf-Nonius, B.V. | 2015 | — |
| +2 | K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024 | — |
| +3 | K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023 | — |
| +2 | K150695 | Modpod | Hollywog, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 HCC? 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 HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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, K053223 (Chattanooga Group, 2006) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K881416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881416: Myotrac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881416
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026