510(k) · Cleared
ClearedCurapuls 419 Diathermy Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Henley Intl. · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on May 30, 1986 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 63 later devices descend from it.
- Decided
- May 30, 1986
- Review
- 58 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 1 citing it directly.
- This deviceK861248 Curapuls 419 Diathermy UnitHenley Intl. · 1986
- Descendant · cites it directly · 62 of its ownK022458 Auto*Therm 395, Model ME 395Mettler Electronics Corp. · 2002
- Descendant · 2 generations on · 61 of its ownK083433 Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy…Chattanooga Group · 2009 · Recalled
- Descendant · 3 generations on · 54 of its ownK090221 Reaction SystemViora, Ltd. · 2009
- Descendant · 4 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 5 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K022458Auto*Therm 395, Model ME 395Mettler Electronics Corp. · 2002 · cites it directly62descendants
- K083433Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Chattanooga Group · 2009 · 2 generations on61descendants
- K090221Reaction SystemViora, Ltd. · 2009 · 3 generations on54descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 4 generations on33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 5 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861248 | Curapuls 419 Diathermy Unit | Henley Intl. | 1986 | — |
| +1 | K022458 | Auto*Therm 395, Model ME 395 | Mettler Electronics Corp. | 2002 | — |
| +2 | K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 | Chattanooga Group | 2009 | 1 |
| +3 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| +4 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +5 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 8 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 IMJ? 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 IMJ device
- #1 K252963 BTL-899TTscore 12.4 · 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (63)
See all 631 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022458 | Auto*Therm 395, Model ME 395 | 2002 | 62 |
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, K022458 (Mettler Electronics Corp., 2002) has gone furthest, with 62 descendants of its own.
How does its category compare?
All IMJ devicesIMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMJ
131in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMJ
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMJ
1in 2019
MAUDE reports naming product code IMJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 3 | 393 | 0 | 3 |
| 2015 | 0 | — | 1 | 5 |
| 2016 | 3 | 131 | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K861248 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861248: Curapuls 419 Diathermy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861248
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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