510(k) · Cleared
ClearedDynatron 900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatronics Corp. · ITH Equipment, Traction, Powered
Cleared on Jan 3, 2000 after a 46-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jan 3, 2000
- Review
- 46 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK993919 Dynatron 900Dynatronics Corp. · 2000
- Descendant · cites it directly · 2 of its ownK052453 Traction System, Digit-Trac 930Ever Prosperous Instrument, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK112074 Everyway Traction Unit, Model Ever-Trac ET-800Everyway Medical Instruments Co.,Ltd · 2012
- Descendant · 2 generations on · 0 of its ownK072064 Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK051680 Dynatron DX2 Traction UnitDynatronics Corp. · 2005
Most influential descendants
Showing 4 of 4 · See all- K052453Traction System, Digit-Trac 930Ever Prosperous Instrument, Inc. · 2006 · cites it directly2descendants
- K112074Everyway Traction Unit, Model Ever-Trac ET-800Everyway Medical Instruments Co.,Ltd · 2012 · 2 generations on0descendants
- K072064Gravilax Traction SystemTherapeutic Clinical Technologies, Inc. · 2008 · 2 generations on0descendants
- K051680Dynatron DX2 Traction UnitDynatronics Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993919 | Dynatron 900 | Dynatronics Corp. | 2000 | — |
| +1 | K052453 | Traction System, Digit-Trac 930 | Ever Prosperous Instrument, Inc. | 2006 | — |
| +2 | K112074 | Everyway Traction Unit, Model Ever-Trac ET-800 | Everyway Medical Instruments Co.,Ltd | 2012 | — |
| +2 | K072064 | Gravilax Traction System | Therapeutic Clinical Technologies, Inc. | 2008 | — |
| +1 | K051680 | Dynatron DX2 Traction Unit | Dynatronics Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITH? 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 ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 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, K052453 (Ever Prosperous Instrument, Inc., 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, 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 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K993919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993919: Dynatron 900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993919
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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