510(k) · Cleared
Clearedsam X1 Long Duration Ultrasound Device
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 Aug 18, 2021 as substantially equivalent to K191568 (ZetrOZ Systems, LLC, 2020) after a 96-day review. Its family tree reaches back 3 generations to 2012. 1 later device descends from it.
- Decided
- Aug 18, 2021
- Review
- 96 days
- Class
- Class II
- Product code
- PFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K120171 (2012). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK120171 Accusonic AdvantageMetron Medical Australia, Pty, Ltd. · 2012
- 2 generations backK130978 ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013
- 1 generation backK191568 sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020
- This deviceK211513 sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021
- Descendant · cites it directly · 0 of its ownK233210 sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K120171 | Accusonic Advantage | Metron Medical Australia, Pty, Ltd. | 2012 | — |
| −2 | K130978 | ZTX Ultrasonic Diathermy Device | Zetroz, Inc. | 2013 | — |
| −1 | K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 | — |
| 0 (this device) | K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2021 | — |
| +1 | K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K191568 | sam 2.0 Long Duration Ultrasound SystemSummary page 4…gulation Class: Class II Product Code: PFW Predicate Device: sam 2.0 Long Duration Ultrasound System (K191568) Indications for Use: The sam X1 Long Duration Ultrasound Device is intended for home use to apply ultrasonic ene… | 2020 |
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 |
|---|---|---|---|
| K233210 | sam CS Long Duration Ultrasound Device | 2023 | 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 9 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K233210 (ZetrOZ Systems, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K191568.
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. 2021, 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 X1 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/K211513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211513: sam X1 Long Duration Ultrasound Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211513
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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