510(k) · Cleared
ClearedBTL-785MJ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · NUW Stimulator, Muscle, Powered, Dental
Cleared on May 9, 2025 as substantially equivalent to K203525 (Ito Co., Ltd., 2021) after a 203-day review. Its family tree reaches back 3 generations to 1984.
- Decided
- May 9, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- NUW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842223 (1984). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 NUW? 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 NUW device
- #1 K203525 D functionscore 4.6 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K203525 | D functionSummary page 6…r the following 510(k) Premarket Notification numbers: Primary predicate: Device name: D function Original 510(k) Sponsor: ITO CO., LTD. 510(k) Number: K203525 Reference device: Device name: BTL-785BNF-E Original 510(k) Sponsor: BTL Industries, Inc. 510(k) Number: K2425… | 2021 |
| † | K242532 | BTL-785BNF-E | 2024 |
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 41 years and passes through 4 companies; a new generation was cleared every 17.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All NUW devicesNUW Stimulator, Muscle, Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NUW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUW
Too few NUW 510(k)s in any year since 2007 to give a median.
Recalls per year · NUW
No recall names NUW since 2007.
Adverse event reports per year · NUW
No MAUDE report names NUW since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BTL-785MJ device with the controller and single-use applicators has the following indications
for use:
1. To relieve symptoms associated with muscle spasm, to treat temporomandibular joint (TMJ)
dysfunction and associated pain
2. Muscle re-education
3. Increasing blood flow
4. Maintain or increase mandibular range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243290: BTL-785MJ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243290
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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