510(k) · Cleared
ClearedAccusonic Advantage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metron Medical Australia, Pty, Ltd. · IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Cleared on May 4, 2012 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- May 4, 2012
- Review
- 105 days
- Class
- Class II
- Product code
- IMI
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK120171 Accusonic AdvantageMetron Medical Australia, Pty, Ltd. · 2012
- Descendant · cites it directly · 7 of its ownK130978 ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK191568 sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020
- Descendant · 3 generations on · 1 of its ownK223019 sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC · 2023
- Descendant · 3 generations on · 1 of its ownK222098 ManaSport+Manamed, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK211513 sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K130978ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013 · cites it directly7descendants
- K191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020 · 2 generations on6descendants
- K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC · 2023 · 3 generations on1descendant
- K222098ManaSport+Manamed, Inc. · 2023 · 3 generations on1descendant
- K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120171 | Accusonic Advantage | Metron Medical Australia, Pty, Ltd. | 2012 | — |
| +1 | K130978 | ZTX Ultrasonic Diathermy Device | Zetroz, Inc. | 2013 | — |
| +2 | K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 | — |
| +3 | K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | 2023 | — |
| +3 | K222098 | ManaSport+ | Manamed, Inc. | 2023 | — |
| +3 | K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 10.4 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130978 | ZTX Ultrasonic Diathermy Device | 2013 | 7 |
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?
- Of its descendants, K130978 (Zetroz, Inc., 2013) has gone furthest, with 7 descendants of its own.
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. 2012, this device’s year, is highlighted.
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?
The indications for use are:
1. Relief or reduction of pain;
2. Reduction of muscle spasm;
3. Joint contracture; and
4. Local increase in circulation.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120171 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120171: Accusonic Advantage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120171
Report an extraction error
Are you the manufacturer?
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