510(k) · Cleared
ClearedAS 1000 Ultrasound 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 Jun 19, 2009 as substantially equivalent to K050129 (Celleration, Inc., 2005) and 2 other predicates after a 67-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 19, 2009
- Review
- 67 days
- Class
- Class II
- Product code
- NRB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945062 (1995). 21 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- 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 deviceK091038 AS 1000 Ultrasound Wound Therapy SystemArobella Medical, LLC · 2009
View 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) | 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 |
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 |
|---|---|---|---|
| * | K050129 | Celleration Mist Therapy System 5.1Summary page 1…NRB 807.92(a)(3) Predicate Device(s) Celleration Celleration Mist Therapy System K050129 Arobella Medical, LLC AR1 000 Ultrasonic Wound Therapy System K062544 DeRoyal Jetox-ND… | 2005 |
| * | K062544 | AR1000 Ultrasonic Wound Therapy SystemSummary page 1…evice(s) Celleration Celleration Mist Therapy System K050129 Arobella Medical, LLC AR1 000 Ultrasonic Wound Therapy System K062544 DeRoyal Jetox-ND Class I Smith & Nephew VersaJet Hydrosur… | 2007 |
| * | K060782 | Versajet Hydrosurgery System and HandpieceSummary page 1…K062544 DeRoyal Jetox-ND Class I Smith & Nephew VersaJet Hydrosurgery System K060782 807.92(a)(4) Device Description The AS1000 Ultrasonic Wound Therapy System promotes wound… | 2006 |
| * | — | DeRoyal JetOx-ND Named without a submission number | |
| * | — | DeRoyal JetOx HDC Named without a submission number |
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 2.2 years on median.
- 4 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K050129.
How does its category compare?
All NRB devicesNRB Wound Cleaner, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Promotes wound healing through lavage of wound tissue (acute and chronic wounds, burns, diseased or necrotic tissue) and maintenance debridement for the removal of debris, exudates, fragments, bacteria and other matter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091038 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091038: AS 1000 Ultrasound 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/K091038
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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