510(k) · Cleared
ClearedDynatron 550
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 1, 1995 after a 519-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 118 later devices descend from it.
- Decided
- Sep 1, 1995
- Review
- 519 days
- Class
- Class II
- Product code
- LIH
- Recalls
- None
- Predicates
- 0
118 later devices descend from it, 2 citing it directly.
- This deviceK941577 Dynatron 550Dynatronics Corp. · 1995
- Descendant · cites it directly · 79 of its ownK981976 Acutron Mentor Model 961Microcurrent Research, Inc. · 1998
- Descendant · 2 generations on · 78 of its ownK990787 TRIO 300Ito Co., Ltd. · 1999
- Descendant · 3 generations on · 63 of its ownK023231 Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003
- Descendant · cites it directly · 37 of its ownK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- Descendant · 4 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K981976Acutron Mentor Model 961Microcurrent Research, Inc. · 1998 · cites it directly79descendants
- K990787TRIO 300Ito Co., Ltd. · 1999 · 2 generations on78descendants
- K023231Elfcare Device, Models 314A Through 314GMediseb, Ltd. · 2003 · 3 generations on63descendants
- K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…Dynatronics Corp. · 2003 · cites it directly37descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 4 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941577 | Dynatron 550 | Dynatronics Corp. | 1995 | — |
| +1 | K981976 | Acutron Mentor Model 961 | Microcurrent Research, Inc. | 1998 | — |
| +2 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| +3 | K023231 | Elfcare Device, Models 314A Through 314G | Mediseb, Ltd. | 2003 | — |
| +1 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| +4 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 9 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 11 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 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? (118)
See all 1182 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, K981976 (Microcurrent Research, Inc., 1998) has gone furthest, with 79 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/K941577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941577: Dynatron 550.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941577
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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