510(k) · Cleared
ClearedMisonix Sonicone (R) Ultrasonic 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 Dec 1, 2011 as substantially equivalent to K062544 (Arobella Medical, LLC, 2007) and 2 other predicates after a 66-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.
- Decided
- Dec 1, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- NRB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945062 (1995). 24 ancestors in all, the oldest K801623 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 4 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 3 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 2 generations backK050129 Celleration Mist Therapy System 5.1Celleration, Inc. · 2005
- 1 generation backK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- This deviceK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
- Descendant · cites it directly · 0 of its ownK123980 Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −4 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −3 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −2 | K050129 | Celleration Mist Therapy System 5.1 | Celleration, Inc. | 2005 | — |
| −1 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| 0 (this device) | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +1 | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K062544 | AR1000 Ultrasonic Wound Therapy SystemSummary page 1…Predicate Device Information Predicate Devices Arobella Medical LLC AR 1000 Ultrasonic Wound Therapy System K062544 Misonix Inc. Alliger Ultrasonic Surgical System AUSS-6… | 2007 |
| * | K050776 | Auss-6 Ultrasonic Surgical Aspirator SystemSummary page 1…Therapy System K062544 Misonix Inc. Alliger Ultrasonic Surgical System AUSS-6 K050776 Microtek Medical Inc. Equipment Drapes K050322 4. Device Description The Son… | 2005 |
| * | K050322 | Microtek Equipment DrapesSummary page 1…x Inc. Alliger Ultrasonic Surgical System AUSS-6 K050776 Microtek Medical Inc. Equipment Drapes K050322 4. Device Description The SonicOne Ultrasonic Wound Care System is comprised… | 2005 |
What descends from it? (2)
2 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 16 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 24 ancestors have a recall of any class.
- Of its descendants, K131096 (Arobella Medical, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K062544.
How does its category compare?
All NRB devicesNRB Wound Cleaner, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridernent and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of anl ultrasonic aspirator with sharp debridement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112782: Misonix Sonicone (R) Ultrasonic 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/K112782
Report an extraction error
Are you the manufacturer?
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