510(k) · Cleared
ClearedSoring GMBH Sonoca 180/190
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soring GmbH Medizintechnik · LFL Instrument, Ultrasonic Surgical
Cleared on Nov 13, 2001 as substantially equivalent to K992026 (Soring GmbH Medizintechnik, 1999) after an 89-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it.
- Decided
- Nov 13, 2001
- Review
- 89 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K942095 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942095 Sonoca IiiHoll Meditronics, Inc. · 1994
- 1 generation backK992026 Soring GMBH, Sonoca 300Soring GmbH Medizintechnik · 1999
- This deviceK012753 Soring GMBH Sonoca 180/190Soring GmbH Medizintechnik · 2001
- Descendant · cites it directly · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK131096 AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK123980 Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · cites it directly5descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 2 generations on2descendants
- K072904Sonoca 180/195 Wound Care SystemSoering GmbH · 2008 · cites it directly1descendant
- K131096AR1000 Series Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2014 · 2 generations on0descendants
- K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942095 | Sonoca Iii | Holl Meditronics, Inc. | 1994 | — |
| −1 | K992026 | Soring GMBH, Sonoca 300 | Soring GmbH Medizintechnik | 1999 | — |
| 0 (this device) | K012753 | Soring GMBH Sonoca 180/190 | Soring GmbH Medizintechnik | 2001 | — |
| +1 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +2 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +1 | K072904 | Sonoca 180/195 Wound Care System | Soering GmbH | 2008 | — |
| +2 | K131096 | AR1000 Series Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2014 | — |
| +3 | K123980 | Sonicone Plus Ultrasound Wound Care System and Accessories | Misonix, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K992026 | Soring GMBH, Sonoca 300Summary page 1…a 190, Sonoca 180 Common Name: Instrument, Ultrasonic Surgical Classification Name: General & Plastic Surgery Predicate Device: Applicant: Séring GmbH 510(k) Number: K992026 Device: Sonoca 300 Device Description: SONOCA 180 & 190 is a desktop unit that controls ultrasonic handpieces used in general… | 1999 |
What descends from it? (6)
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 7 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K062544 (Arobella Medical, LLC, 2007) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K992026.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.
Typical users of this system are trained professionals; physicians, nurses, and technicians.
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/K012753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012753: Soring GMBH Sonoca 180/190.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012753
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026