510(k) · Cleared
ClearedAR1000 Series Ultrasonic Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arobella Medical, LLC · NRB Wound Cleaner, Ultrasound
Cleared on May 16, 2014 as substantially equivalent to K062544 (Arobella Medical, LLC, 2007) and 4 other predicates after a 393-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- May 16, 2014
- Review
- 393 days
- Class
- Class II
- Product code
- NRB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K945062 (1995). 28 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 backK072904 Sonoca 180/195 Wound Care SystemSoering GmbH · 2008
- This deviceK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
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 | K072904 | Sonoca 180/195 Wound Care System | Soering GmbH | 2008 | — |
| 0 (this device) | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
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 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (5)
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…f 21 CFR 807.92, Arobella Medical is submitting the following 510(k) summary for the AR1000 Ultrasonic Wound Therapy System and its variants. (Reference previous 51 0(k) K062544) 807 .92(~a)( 1) Submitter Information Arobella Medical LILC 5929 Baker Road, Suite 470 Minneto… | 2007 |
| * | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesSummary page 11…ound Wound Therapy System and its variants is substantially equivalent to the previously cleared ARi 000 Ultrasound Wound Therapy System (K062544), the Misonix SonicOne (K1 12782) system, Celleration MIST (K122246) system, the Soring Sonoca (K072904) systems, and the Ethicon (K002906) system. 1.0 Efficacy T… | 2011 |
| * | K122246 | Mist 360 Single Use Applicator Kit, Mist 360 Single Use Applicator Kit, Case of 12Summary page 11…riants is substantially equivalent to the previously cleared ARi 000 Ultrasound Wound Therapy System (K062544), the Misonix SonicOne (K1 12782) system, Celleration MIST (K122246) system, the Soring Sonoca (K072904) systems, and the Ethicon (K002906) system. 1.0 Efficacy This device, like the predicates, is… | 2012 |
| * | K072904 | Sonoca 180/195 Wound Care SystemSummary page 1…Ki112782 Celferation Celleration Mist Therapy System Ki122246 Soring Gmbh SONOCA 180 /185 Wound Care System K072904 Section 005_51 0(k) Summary Page 005-1 of 005-13 510(k) Summary 510(k) -ARlOQ… | 2008 |
| * | K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07Summary page 11…trasound Wound Therapy System (K062544), the Misonix SonicOne (K1 12782) system, Celleration MIST (K122246) system, the Soring Sonoca (K072904) systems, and the Ethicon (K002906) system. 1.0 Efficacy This device, like the predicates, is directed for single (1) treatment, and total recommended treatments sh… | 2000 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 28 ancestors have a recall of any class.
- 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. 2014, 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 AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via: * Selective and non-selective dissection and fragmentation of soft and or hard tissue; * Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, bums) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and esehar, fibrin, tissue exudates, bacteria and other…
Read the full statement (247 words)
The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via:
* Selective and non-selective dissection and fragmentation of soft and or hard tissue;
* Surgical, excisional or sharp-edge wound debridement (acute and chronic wounds, bums) for the removal of nonviable tissue including but not limited to diseased tissue, necrotic tissue, slough and esehar, fibrin, tissue exudates, bacteria and other matter.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DM).
The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing via:
* Site cleansing irrigation and lavage of wound tissue (acute and chronic wounds, bums, diseased or necrotic tissue);
* Contact and or non-contact maintenance debridement for the removal of debris, exudates, fragments, bacteria, slough, fibrin, excised or fragmented tissue, and other matter.
IRRIGATION (LAVAGE) FLUID
* Irrigation fluid may be sterile de-ionized water, sterile saline solution, other approved wound therapy or debridemnent solution.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DMV).
The AR1000 Series and its variants produce and deliver low frequency ultrasound used to promote wound healing by: Preparing the wound bed for graft or other subsequent procedures using contact and or non-contact techniques to achieve wound debridement.
Patient population is patients of any age with one or more wounds. Patient population may also exhibit diabetes mellitus (DMV).
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/K131096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131096: AR1000 Series Ultrasonic Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131096
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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