510(k) · Cleared
ClearedStaodyn Ems+2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Staodyne, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Aug 11, 1993 after a 224-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 77 later devices descend from it.
- Decided
- Aug 11, 1993
- Review
- 224 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
77 later devices descend from it, 4 citing it directly.
- This deviceK926510 Staodyn Ems+2Staodyne, Inc. · 1993
- Descendant · cites it directly · 56 of its ownK050046 Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005
- Descendant · 2 generations on · 26 of its ownK093324 Empi ContinuumEmpi · 2010
- Descendant · 3 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · 4 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 2 generations on · 19 of its ownK123354 Revitive IXActegy, Ltd. · 2013
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K050046Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110SCompex Technologies, Inc. · 2005 · cites it directly56descendants
- K093324Empi ContinuumEmpi · 2010 · 2 generations on26descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 3 generations on25descendants
- K153704StriveDjo, LLC · 2016 · 4 generations on24descendants
- K123354Revitive IXActegy, Ltd. · 2013 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926510 | Staodyn Ems+2 | Staodyne, Inc. | 1993 | — |
| +1 | K050046 | Rehabilicare IF 3 Wave Interferential Stimulator System, Model 7110S | Compex Technologies, Inc. | 2005 | — |
| +2 | K093324 | Empi Continuum | Empi | 2010 | — |
| +3 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +4 | K153704 | Strive | Djo, LLC | 2016 | — |
| +2 | K123354 | Revitive IX | Actegy, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 2 | 0 |
| 2019 | 8 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (77)
See all 774 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, K050046 (Compex Technologies, Inc., 2005) has gone furthest, with 56 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
https://510kreport.com/device/K926510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926510: Staodyn Ems+2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926510
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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