510(k) · Cleared
Clearedsam CS 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 Oct 25, 2023 as substantially equivalent to K211513 (ZetrOZ Systems, LLC, 2021) after a 27-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Oct 25, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- PFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K120171 (2012). No later device cites it as a predicate yet.
- Root · 4 generations backK120171 Accusonic AdvantageMetron Medical Australia, Pty, Ltd. · 2012
- 3 generations backK130978 ZTX Ultrasonic Diathermy DeviceZetroz, Inc. · 2013
- 2 generations backK191568 sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC · 2020
- 1 generation backK211513 sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2021
- This deviceK233210 sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K120171 | Accusonic Advantage | Metron Medical Australia, Pty, Ltd. | 2012 | — |
| −3 | K130978 | ZTX Ultrasonic Diathermy Device | Zetroz, Inc. | 2013 | — |
| −2 | K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020 | — |
| −1 | K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2021 | — |
| 0 (this device) | K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2023 | — |
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 |
|---|---|---|---|
| * | K211513 | sam X1 Long Duration Ultrasound DeviceSummary page 5…90.5300; Ultrasonic diathermy. Class: II Product Code: PFW Predicate Devices: sam X1 Long Duration Ultrasound Device (K211513) Indications for Use: The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generat… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
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. 2023, 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 CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233210: sam CS 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/K233210
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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