510(k) · Cleared
ClearedSonicone Plus Ultrasound Wound Care System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Misonix, Inc. · NRB Wound Cleaner, Ultrasound
Cleared on Mar 5, 2013 as substantially equivalent to K112782 (Misonix, Inc., 2011) and 2 other predicates after a 69-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Mar 5, 2013
- Review
- 69 days
- Class
- Class II
- Product code
- NRB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K945062 (1995). 26 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 4 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 3 generations backK050129 Celleration Mist Therapy System 5.1Celleration, Inc. · 2005
- 2 generations backK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- 1 generation backK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- This deviceK123980 Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −4 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −3 | K050129 | Celleration Mist Therapy System 5.1 | Celleration, Inc. | 2005 | — |
| −2 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| −1 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| 0 (this device) | K123980 | Sonicone Plus Ultrasound Wound Care System and Accessories | Misonix, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 NRB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | 2011 |
| * | K070313 | Misonix, Inc., Auss-7 Ultrasonic Surgical Aspirator SystemSummary page 1…K 1I12782 Misonix Inc. Alliger Ultrasonic Surgical System AUSS-7 K070313 Microtek Medical Inc. Equipment Drapes K050322 4. 1)evice lDescription The Son… | 2007 |
| * | K050322 | Microtek Equipment DrapesSummary page 1…x Inc. Alliger Ultrasonic Surgical System AUSS-7 K070313 Microtek Medical Inc. Equipment Drapes K050322 4. 1)evice lDescription The SonicOne Plus Ultrasonic Wound Care System and Acc… | 2005 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K112782.
How does its category compare?
All NRB devicesNRB Wound Cleaner, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NRB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NRB
Too few NRB 510(k)s in any year since 2007 to give a median.
Recalls per year · NRB
No recall names NRB since 2007.
Adverse event reports per year · NRB
1in 2025
MAUDE reports naming product code NRB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Misonix SonicOne Ultrasonic Would Care System and Accessories are indicated for use in the debridement of wounds, such as, but not limited to, bum wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123980: Sonicone Plus Ultrasound Wound Care System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123980
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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