510(k) · Cleared
ClearedCurapuls 670
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enraf-Nonius, B.V. · IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Cleared on Jun 25, 2025 as substantially equivalent to K182363 (BTL Industries, Inc., 2019) after a 268-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Jun 25, 2025
- Review
- 268 days
- Class
- Class II
- Product code
- IMJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K861248 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK861248 Curapuls 419 Diathermy UnitHenley Intl. · 1986
- 4 generations backK022458 Auto*Therm 395, Model ME 395Mettler Electronics Corp. · 2002
- 3 generations backK083433 Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy…Chattanooga Group · 2009 · Recalled
- 2 generations backK120093 BTL EliteBTL Industries, Inc. · 2012
- 1 generation backK182363 BTL-703BTL Industries, Inc. · 2019
- This deviceK243112 Curapuls 670Enraf-Nonius, B.V. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K861248 | Curapuls 419 Diathermy Unit | Henley Intl. | 1986 | — |
| −4 | K022458 | Auto*Therm 395, Model ME 395 | Mettler Electronics Corp. | 2002 | — |
| −3 | K083433 | Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 | Chattanooga Group | 2009 | 1 |
| −2 | K120093 | BTL Elite | BTL Industries, Inc. | 2012 | — |
| −1 | K182363 | BTL-703 | BTL Industries, Inc. | 2019 | — |
| 0 (this device) | K243112 | Curapuls 670 | Enraf-Nonius, B.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K182363 | BTL-703Summary page 5…Class II 3. Predicate Device: BTL-703 Company Name: BTL Industries, Inc. K182363 4. Device Description: The Curapuls 670 is a two-channel microprocessor-controlled unit for pulsed shortwave therapy. Thro… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 8 ancestors has a recall of any class.
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. 2025, 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?
The Curapuls 670 is indicated to be used for applying therapeutic deep heat in body tissues for the treatment of 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/K243112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243112: Curapuls 670.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243112
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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