510(k) · Cleared
ClearedCompex 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodex Medical Systems, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Dec 28, 1994 after a 338-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 231 later devices descend from it.
- Decided
- Dec 28, 1994
- Review
- 338 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
231 later devices descend from it, 2 citing it directly.
- This deviceK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- Descendant · cites it directly · 195 of its ownK011880 Compex SportCompex S.A. · 2002
- Descendant · 2 generations on · 151 of its ownK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- Descendant · 2 generations on · 78 of its ownK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- Descendant · 3 generations on · 58 of its ownK112392 Hivox Biotek Inc.Hivox Biotek, Inc. · 2012
- Descendant · 3 generations on · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
Showing 5 of 231 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 231 · See all- K011880Compex SportCompex S.A. · 2002 · cites it directly195descendants
- K060846Therapeutic Massage CompanionEndurance Therapeutics · 2007 · 2 generations on151descendants
- K102598HI-Dow-XPHi-Dow International, Inc. · 2011 · 2 generations on78descendants
- K112392Hivox Biotek Inc.Hivox Biotek, Inc. · 2012 · 3 generations on58descendants
- K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · 3 generations on55descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| +1 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| +2 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| +2 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| +3 | K112392 | Hivox Biotek Inc. | Hivox Biotek, Inc. | 2012 | — |
| +3 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 21 | 0 |
| 2015 | 17 | 0 |
| 2016 | 8 | 0 |
| 2017 | 16 | 0 |
| 2018 | 11 | 0 |
| 2019 | 20 | 0 |
| 2020 | 16 | 0 |
| 2021 | 17 | 0 |
| 2022 | 16 | 0 |
| 2023 | 16 | 0 |
| 2024 | 8 | 0 |
| 2025 | 19 | 0 |
| 2026 | 11 | 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 19.6 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (231)
See all 2312 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, K011880 (Compex S.A., 2002) has gone furthest, with 195 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/K940301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K940301: Compex 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940301
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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