510(k) · Cleared
ClearedZTX Ultrasonic Diathermy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zetroz, Inc. · PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Cleared on Nov 6, 2013 as substantially equivalent to K120171 (Metron Medical Australia, Pty, Ltd., 2012) after a 211-day review. Its family tree reaches back 1 generation to 2012. 7 later devices descend from it.
- Decided
- Nov 6, 2013
- Review
- 211 days
- Class
- Class II
- Product code
- PFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K120171 (2012). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK120171 Accusonic AdvantageMetron Medical Australia, Pty, Ltd. · 2012
- This deviceK130978 ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013
- Descendant · cites it directly · 6 of its ownK191568 sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK223019 sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC · 2023
- Descendant · 2 generations on · 1 of its ownK222098 ManaSport+Manamed, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK211513 sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK260076 SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020 · cites it directly6descendants
- K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC · 2023 · 2 generations on1descendant
- K222098ManaSport+Manamed, Inc. · 2023 · 2 generations on1descendant
- K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021 · 2 generations on1descendant
- K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K120171 | Accusonic Advantage | Metron Medical Australia, Pty, Ltd. | 2012 | — |
| 0 (this device) | K130978 | ZTX Ultrasonic Diathermy Device | Zetroz, Inc. | 2013 | — |
| +1 | K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 | — |
| +2 | K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | 2023 | — |
| +2 | K222098 | ManaSport+ | Manamed, Inc. | 2023 | — |
| +2 | K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2021 | — |
| +3 | K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 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 PFW? 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 PFW device
- #1 K260076 SAM 3.0 Multi-Hour Continuous Ultrasound Devicescore 12.1 · 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 |
|---|---|---|---|
| * | K120171 | Accusonic AdvantageSummary page 2…EQUIVALENCE SUMMARY 5.7.1 Predicate Devices The ZTX Ulrasound Diathermy Device is substantially equivalent 1o the METRON MEDICAL AUSTRALIA PTY LTD, ACCUSONIC ADVANTAGE (K120171). Section 12 contains a detailed comparison of the ZTX Ultrasound Diathermy Device with the predicate device. Bel… | 2012 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191568 | sam 2.0 Long Duration Ultrasound System | 2020 | 6 |
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?
- Its one ancestor has no recall.
- Of its descendants, K191568 (ZetrOZ Systems, LLC, 2020) has gone furthest, with 6 descendants of its own.
How does its category compare?
All PFW devicesPFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · PFW
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PFW
Too few PFW 510(k)s in any year since 2007 to give a median.
Recalls per year · PFW
No recall names PFW since 2007.
Adverse event reports per year · PFW
No MAUDE report names PFW 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ZTX Ultrasonic Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.
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/K130978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130978: ZTX Ultrasonic Diathermy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130978
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