510(k) · Cleared
Clearedsam 2.0 Long Duration Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZetrOZ Systems, LLC · PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Cleared on Mar 6, 2020 as substantially equivalent to K130978 (Zetroz, Inc., 2013) after a 267-day review. Its family tree reaches back 2 generations to 2012. 6 later devices descend from it.
- Decided
- Mar 6, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- PFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K120171 (2012). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK120171 Accusonic AdvantageMetron Medical Australia, Pty, Ltd. · 2012
- 1 generation backK130978 ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013
- This deviceK191568 sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020
- Descendant · cites it directly · 1 of its ownK223019 sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC · 2023
- Descendant · cites it directly · 1 of its ownK222098 ManaSport+Manamed, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK211513 sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK260076 SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC · 2026
- Descendant · cites it directly · 0 of its ownK240788 Ultrasound StimulatorJkh Health Co., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC · 2023 · cites it directly1descendant
- K222098ManaSport+Manamed, Inc. · 2023 · cites it directly1descendant
- K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021 · cites it directly1descendant
- K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC · 2026 · 2 generations on0descendants
- K240788Ultrasound StimulatorJkh Health Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K120171 | Accusonic Advantage | Metron Medical Australia, Pty, Ltd. | 2012 | — |
| −1 | K130978 | ZTX Ultrasonic Diathermy Device | Zetroz, Inc. | 2013 | — |
| 0 (this device) | K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 | — |
| +1 | K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | 2023 | — |
| +1 | K222098 | ManaSport+ | Manamed, Inc. | 2023 | — |
| +1 | K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2021 | — |
| +2 | K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | 2026 | — |
| +1 | K240788 | Ultrasound Stimulator | Jkh Health Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K130978 | ZTX Ultrasonic Diathermy DeviceSummary page 4…§890.5300; Ultrasonic diathermy. Class: II Product Code: PFW Predicate Devices: ZetrOZ Ultrasonic Diathermy Device (K130978) Indications for Use: The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to genera… | 2013 |
What descends from it? (6)
4 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K223019 (ZetrOZ Systems, LLC, 2023) has gone furthest, with 1 descendant 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. 2020, 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 sam 2.0 Long Duration Ultrasound Device is intended for home use 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.
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/K191568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191568: sam 2.0 Long Duration Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191568
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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