510(k) · Cleared
Recalled · Class II · 2012AR1000 Ultrasonic Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arobella Medical, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Jan 3, 2007 as substantially equivalent to K050776 (Misonix, Inc., 2005) and 3 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 3, 2007
- Review
- 126 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K945062 (1995). 20 ancestors in all, the oldest K801623 (1980). 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 2 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 1 generation backK050129 Celleration Mist Therapy System 5.1Celleration, Inc. · 2005
- This deviceK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007
- Descendant · cites it directly · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK072904 Sonoca 180/195 Wound Care SystemSoering GmbH · 2008
- Descendant · cites it directly · 0 of its ownK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK123980 Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK091038 AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC · 2009
Most influential descendants
Showing 5 of 5 · See all- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · cites it directly2descendants
- K072904Sonoca 180/195 Wound Care SystemSoering GmbH · 2008 · cites it directly1descendant
- K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014 · cites it directly0descendants
- K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013 · 2 generations on0descendants
- K091038AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −3 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −2 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −1 | K050129 | Celleration Mist Therapy System 5.1 | Celleration, Inc. | 2005 | — |
| 0 (this device) | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | — |
| +1 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +1 | K072904 | Sonoca 180/195 Wound Care System | Soering GmbH | 2008 | — |
| +1 | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
| +2 | K123980 | Sonicone Plus Ultrasound Wound Care System and Accessories | Misonix, Inc. | 2013 | — |
| +1 | K091038 | AS 1000 Ultrasound Wound Therapy System | Arobella Medical, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 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 LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K050776 | Auss-6 Ultrasonic Surgical Aspirator SystemSummary page 1…FQH; LFL; NRB 807.92(a)(3) Predicate Device(s) Misonix, Inc. SonicOne Ultrasonic Wound Debridement System K050776 Soring Gmbh Sonoca 180 Ultrasound Dissection K012753 Smith & Nephew VersaJet H… | 2005 |
| * | K012753 | Soring GMBH Sonoca 180/190Summary page 1…nix, Inc. SonicOne Ultrasonic Wound Debridement System K050776 Soring Gmbh Sonoca 180 Ultrasound Dissection K012753 Smith & Nephew VersaJet Hydrosurgery System K060782 Celleration Celleratio… | 2001 |
| * | K060782 | Versajet Hydrosurgery System and HandpieceSummary page 1…ng Gmbh Sonoca 180 Ultrasound Dissection K012753 Smith & Nephew VersaJet Hydrosurgery System K060782 Celleration Celleration Mist Therapy System K050129 807.92(a)(4)… | 2006 |
| * | K050129 | Celleration Mist Therapy System 5.1Summary page 1…h & Nephew VersaJet Hydrosurgery System K060782 Celleration Celleration Mist Therapy System K050129 807.92(a)(4) Device Description The AR1000 system uses ultrasound for selective tissue dis… | 2005 |
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2012 | Class II | Z-0534-2013 | Nonconforming Material/Component | This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K112782 (Misonix, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K050776.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
Selective dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, burns, diseased or necrotic tissue), and cleansing irrigation of the site for the removal of debris, exudates, fragments, and other matter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062544 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062544: AR1000 Ultrasonic Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062544
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