510(k) · Cleared
ClearedSonicator Plus 930, Model ME 930
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mettler Electronics Corp. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on Oct 17, 2001 as substantially equivalent to K984142 (Mettler Electronics Corp., 1999) after a 22-day review. Its family tree reaches back 1 generation to 1999. 11 later devices descend from it.
- Decided
- Oct 17, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K984142 (1999). 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- This deviceK013192 Sonicator Plus 930, Model ME 930Mettler Electronics Corp. · 2001
- Descendant · cites it directly · 5 of its ownK130888 Sonopulse/ Sonopulse IiiIbramed- Industria Brazileria DE Equipamentos Medi · 2014
- Descendant · 2 generations on · 4 of its ownK202788 Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto · 2021
- Descendant · cites it directly · 4 of its ownK131309 Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIbramed Equipamentos Medicos · 2014
- Descendant · 3 generations on · 3 of its ownK230472 Sonopuls 190Enraf-Nonius, B.V. · 2023
- Descendant · 2 generations on · 3 of its ownK161628 JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K130888Sonopulse/ Sonopulse IiiIbramed- Industria Brazileria DE Equipamentos Medi · 2014 · cites it directly5descendants
- K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E Orto · 2021 · 2 generations on4descendants
- K131309Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIbramed Equipamentos Medicos · 2014 · cites it directly4descendants
- K230472Sonopuls 190Enraf-Nonius, B.V. · 2023 · 3 generations on3descendants
- K161628JAS Pulse (TM) Ultrasonic TherapyBonutti Research, Inc. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| 0 (this device) | K013192 | Sonicator Plus 930, Model ME 930 | Mettler Electronics Corp. | 2001 | — |
| +1 | K130888 | Sonopulse/ Sonopulse Iii | Ibramed- Industria Brazileria DE Equipamentos Medi | 2014 | — |
| +2 | K202788 | Sonomed IV, Sonomed V | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | 2021 | — |
| +1 | K131309 | Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZ | Ibramed Equipamentos Medicos | 2014 | — |
| +3 | K230472 | Sonopuls 190 | Enraf-Nonius, B.V. | 2023 | — |
| +2 | K161628 | JAS Pulse (TM) Ultrasonic Therapy | Bonutti Research, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 IMI? 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 IMI device
- #1 K240788 Ultrasound Stimulatorscore 10.3 · 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 |
|---|---|---|---|
| * | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994Summary page 1…and Muscle Stimulator ¢. COMMON NAME: Combination ultrasound and Muscle Stimulator Predicate Device: a. TRADE NAME: Sonicator® Plus 992, Model ME 992 b. 510(k) Number: K984142 Description of Proposed Device: The Sonicator Plus 930 is a two-channel combination unit for therapeutic ultrasound and muscle… | 1999 |
What descends from it? (11)
See all 114 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?
How does its category compare?
All IMI devicesIMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IMI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IMI
150in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IMI
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMI
2in 2025
MAUDE reports naming product code IMI, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 3 | 150 | 0 | 2 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Therapeutic Ultrasound 1. Pain relief 2. Reduction of muscle spasm 3. Localized increase in blood flow 4. Increase range of motion of contracted joints using heat and stretch techniques. Neuromuscular Stimulation 1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms) 2. Temporary relaxation of muscle spasm (all waveforms) 3. Prevention of post-surgical…
Read the full statement (108 words)
Therapeutic Ultrasound
1. Pain relief
2. Reduction of muscle spasm
3. Localized increase in blood flow
4. Increase range of motion of contracted joints using heat and stretch techniques.
Neuromuscular Stimulation
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (Interferential and Pre-modulated waveforms)
2. Temporary relaxation of muscle spasm (all waveforms)
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles (all waveforms)
4. Increase of blood flow in the treatment area (all waveforms)
5. Prevention or retardation of disuse atrophy in post-injury type conditions (all waveforms)
Muscle re-education (all waveforms)
Maintaining or increasing range of motion (all waveforms)
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/K013192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013192: Sonicator Plus 930, Model ME 930.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013192
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026