510(k) · Cleared
ClearedD function
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ito Co., Ltd. · NUW Stimulator, Muscle, Powered, Dental
Cleared on May 5, 2021 as substantially equivalent to K031998 (Myotronics-Noromed, Inc., 2003) after a 155-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it.
- Decided
- May 5, 2021
- Review
- 155 days
- Class
- Class II
- Product code
- NUW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K842223 (1984). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K243290BTL-785MJBTL Industries, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842223 | J4 Myo-Monitor | Myo-Tronics Research, Inc. | 1984 | — |
| −1 | K031998 | Model J-5 Mvo-Monitor | Myotronics-Noromed, Inc. | 2003 | — |
| 0 (this device) | K203525 | D function | Ito Co., Ltd. | 2021 | — |
| +1 | K243290 | BTL-785MJ | BTL Industries, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 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 K243290 BTL-785MJscore 9.9 · 3 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 |
|---|---|---|---|
| * | K031998 | Model J-5 Mvo-MonitorSummary page 4…or, Muscle, Powered, Dental Regulatory Class: Ⅱ Product Code: NUW III. PREDICATE DEVICE PRIMARY PREDICATE DEVICE: MODEL J-5 MVO-MONITOR, K031998 REFERENCE DEVICE: TRIO 300, K990787 IV. DEVICE DESCRIPTION This device is a current stimulation device with Therapeutic Ele… | 2003 |
| † | K990787 | TRIO 300 | 1999 |
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 |
|---|---|---|---|
| K243290 | BTL-785MJ | 2025 | 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 37 years and passes through 3 companies; a new generation was cleared every 18.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K243290 (BTL Industries, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K031998.
How does its category compare?
All NUW devicesNUW Stimulator, Muscle, Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203525: D function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203525
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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