510(k) · Cleared
ClearedSonoca 180/195 Wound Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soering GmbH · LFL Instrument, Ultrasonic Surgical
Cleared on May 21, 2008 as substantially equivalent to K012753 (Soring GmbH Medizintechnik, 2001) and 2 other predicates after a 223-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- May 21, 2008
- Review
- 223 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K945062 (1995). 21 ancestors in all, the oldest K801623 (1980). 1 later device descends from it, 1 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 deviceK072904 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
Most influential descendants
Showing 1 of 1 · See all- K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014 · cites it directly0descendants
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) | K072904 | Sonoca 180/195 Wound Care System | Soering GmbH | 2008 | — |
| +1 | 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 |
| 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K012753 | Soring GMBH Sonoca 180/190Summary page 1…gcl aspiration (manual or ~Name sugclutaon ugclpowered) [51(k) ~Numbe~r K012753 K062544 i K050776K926 SORING GMBH 1AR1 000 ULTRASONIC AUS… | 2001 |
| * | K062544 | AR1000 Ultrasonic Wound Therapy SystemSummary page 1…on (manual or ~Name sugclutaon ugclpowered) [51(k) ~Numbe~r K012753 K062544 i K050776K926 SORING GMBH 1AR1 000 ULTRASONIC AUSS-6 ULTRASONIC]… | 2007 |
| * | K050776 | Auss-6 Ultrasonic Surgical Aspirator SystemSummary page 1…sugclutaon ugclpowered) [51(k) ~Numbe~r K012753 K062544 i K050776K926 SORING GMBH 1AR1 000 ULTRASONIC AUSS-6 ULTRASONIC] SORING GMBH Device… | 2005 |
| * | — | Soring GmbH SONOCA 0 ONC30 Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131096 | AR1000 Series Ultrasonic Wound Therapy System | 2014 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K131096 (Arobella Medical, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012753.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The SONOCA 180/185 is an instrument intended for selected ultrasound dissection and fragmentation of tissue, wound debridement (acute and chronic wounds, bums, diseased or necrotic tissue) and cleansing irrigation of the site for removal of debris, exudates, fragments, and other matter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072904 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072904: Sonoca 180/195 Wound Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072904
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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