510(k) · Cleared
ClearedAuto*Therm 395, Model ME 395
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mettler Electronics Corp. · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Sep 26, 2002 as substantially equivalent to K861248 (Henley Intl., 1986) after a 62-day review. Its family tree reaches back 1 generation to 1986. 62 later devices descend from it.
- Decided
- Sep 26, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861248 (1986). 62 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK861248 Curapuls 419 Diathermy UnitHenley Intl. · 1986
- This deviceK022458 Auto*Therm 395, Model ME 395Mettler Electronics Corp. · 2002
- Descendant · cites it directly · 61 of its ownK083433 Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy…Chattanooga Group · 2009 · Recalled
- Descendant · 2 generations on · 54 of its ownK090221 Reaction SystemViora, Ltd. · 2009
- Descendant · 3 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
- Descendant · 4 generations on · 32 of its ownK142093 V20 SystemViora, Ltd. · 2014
- Descendant · 3 generations on · 31 of its ownK150035 V10 systemViora, Ltd. · 2015
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K083433Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Chattanooga Group · 2009 · cites it directly61descendants
- K090221Reaction SystemViora, Ltd. · 2009 · 2 generations on54descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 3 generations on33descendants
- K142093V20 SystemViora, Ltd. · 2014 · 4 generations on32descendants
- K150035V10 systemViora, Ltd. · 2015 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861248 | Curapuls 419 Diathermy Unit | Henley Intl. | 1986 | — |
| 0 (this device) | K022458 | Auto*Therm 395, Model ME 395 | Mettler Electronics Corp. | 2002 | — |
| +1 | K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 | Chattanooga Group | 2009 | 1 |
| +2 | K090221 | Reaction System | Viora, Ltd. | 2009 | — |
| +3 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
| +4 | K142093 | V20 System | Viora, Ltd. | 2014 | — |
| +3 | K150035 | V10 system | Viora, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), the FDA summary (predicates and indications), 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K861248 | Curapuls 419 Diathermy UnitSummary page 1…e diathermy c. COMMONNAME: Shortwave diathermy Predicate Device: a. TRADENAME: Curapuls419 b. 51O(k)Number: K861248 Description of Device: The Auto*Therm 395 is a shortwave diathermy device that operates at 27.12 MHz It providestraditional shor… | 1986 |
What descends from it? (62)
See all 622 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?
- Its one ancestor has no recall.
- Of its descendants, K083433 (Chattanooga Group, 2009) has gone furthest, with 61 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 | — |
What is it indicated for?
Shortwave diathermy delivers energy in the radio band of 27.12 MIiz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:
1. Relieving pain;
2. Reducing muscle spasm;
3. Increasing range of motion of contracted joints using heat and stretch techniques; and
4. Increasing blood flow to tissues in the treatment area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022458 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022458: Auto*Therm 395, Model ME 395.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022458
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026