510(k) · Cleared
ClearedSAM 3.0 Multi-Hour Continuous 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 Apr 28, 2026 as substantially equivalent to K223019 (ZetrOZ Systems, LLC, 2023) after a 106-day review. Its family tree reaches back 4 generations to 2012.
- Decided
- Apr 28, 2026
- Review
- 106 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 backK223019 sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLC · 2023
- This deviceK260076 SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLC · 2026
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 | K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | 2023 | — |
| 0 (this device) | K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | 2026 | — |
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 K191568 sam 2.0 Long Duration Ultrasound Systemscore 11.3 · 2 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 |
|---|---|---|---|
| * | K223019 | sam 2.0 Long Ultrasound DeviceSummary page 5…00; Ultrasonic Diathermy. Class: II Product Code: PFW Primary Predicate: SAM 2.0 Long Duration Ultrasound Device (K223019) Indications For Use: The SAM 3.0 Multi-Hour Continuous Ultrasound Device is intended for home use to apply ultrasonic energy to… | 2023 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.3 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. 2026, 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 3.0 Multi-Hour Continuous 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, the local increase in circulation, and the relief of pain associated with
limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and
shoulder, elbow and ankle tendinopathy).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260076: SAM 3.0 Multi-Hour Continuous 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/K260076
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026