510(k) · Cleared
ClearedThermoPro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Medizinsysteme GmbH · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Nov 14, 2016 as substantially equivalent to K083433 (Chattanooga Group, 2009) after a 131-day review. Its family tree reaches back 3 generations to 1986. 1 later device descends from it.
- Decided
- Nov 14, 2016
- Review
- 131 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K861248 (1986). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK861248 Curapuls 419 Diathermy UnitHenley Intl. · 1986
- 2 generations backK022458 Auto*Therm 395, Model ME 395Mettler Electronics Corp. · 2002
- 1 generation backK083433 Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy…Chattanooga Group · 2009 · Recalled
- This deviceK161862 ThermoProZimmer Medizinsysteme GmbH · 2016
- Descendant · cites it directly · 0 of its ownK252963 BTL-899TTBTL Industries, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252963BTL-899TTBTL Industries, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861248 | Curapuls 419 Diathermy Unit | Henley Intl. | 1986 | — |
| −2 | 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 |
| 0 (this device) | K161862 | ThermoPro | Zimmer Medizinsysteme GmbH | 2016 | — |
| +1 | K252963 | BTL-899TT | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Summary page 4…890.5290 Product Code: IMJ Classification: Class II 3. Predicate Devices: INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 – K083433 4. Device Description: ThermoPro is a shortwave diathermy device for use in applying therapeutic deep heat for selected m… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252963 | BTL-899TT | 2026 | 0 |
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K252963 (BTL Industries, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K083433.
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. 2016, this device’s year, is highlighted.
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?
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
• Pain Relief
• Contractures
• Reduce Muscle Spasm
• Localized increase Blood Flow
• Chronic Inflammatory Conditions
• Bursitis
• Decrease Joint Stiffness
• Tenosynovitis
• Synovitis
• Chronic Inflammatory Pelvic Disease
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161862: ThermoPro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161862
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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