510(k) · Cleared
ClearedDynatron 650
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dynatronics Corp. · LIH Interferential Current Therapy
Cleared on Sep 13, 1995 after a 229-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.
- Decided
- Sep 13, 1995
- Review
- 229 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 1 citing it directly.
- This deviceK950348 Dynatron 650Dynatronics Corp. · 1995
- Descendant · cites it directly · 37 of its ownK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- Descendant · 2 generations on · 28 of its ownK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
- Descendant · 2 generations on · 13 of its ownK043586 Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005
- Descendant · 3 generations on · 12 of its ownK050070 K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005
- Descendant · 3 generations on · 9 of its ownK113017 Sys*Stim 240Mettler Electronics Corp. · 2012
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Dynatronics Corp. · 2003 · cites it directly37descendants
- K040729Solaris D890 Therapy ProbeDynatronics Corp. · 2004 · 2 generations on28descendants
- K043586Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005 · 2 generations on13descendants
- K050070K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005 · 3 generations on12descendants
- K113017Sys*Stim 240Mettler Electronics Corp. · 2012 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950348 | Dynatron 650 | Dynatronics Corp. | 1995 | — |
| +1 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| +2 | K040729 | Solaris D890 Therapy Probe | Dynatronics Corp. | 2004 | — |
| +2 | K043586 | Laser Sys*Stim 540, Model ME 540 | Mettler Electronics Corp. | 2005 | — |
| +3 | K050070 | K-Laser, Models 3,4,4D,6D | Eltech S.R.L | 2005 | — |
| +3 | K113017 | Sys*Stim 240 | Mettler Electronics Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 LIH? 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 LIH device
- #1 K231575 Vecttor VT-300score 7.1 · 2 generations · no Class I recall
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? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional… | 2003 | 37 |
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, K031329 (Dynatronics Corp., 2003) has gone furthest, with 37 descendants of its own.
How does its category compare?
All LIH devicesLIH Interferential Current Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LIH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LIH
Too few LIH 510(k)s in any year since 2007 to give a median.
Recalls per year · LIH
No recall names LIH since 2007.
Adverse event reports per year · LIH
1in 2025
MAUDE reports naming product code LIH, 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 | 0 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K950348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950348: Dynatron 650.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950348
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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