510(k) · Cleared
ClearedSonoca Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Holl Meditronics, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Nov 9, 1994 after a 203-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Nov 9, 1994
- Review
- 203 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK942095 Sonoca IiiHoll Meditronics, Inc. · 1994
- Descendant · cites it directly · 11 of its ownK992026 Soring GMBH, Sonoca 300Soring GmbH Medizintechnik · 1999
- Descendant · 2 generations on · 6 of its ownK012753 Soring GMBH Sonoca 180/190Soring GmbH Medizintechnik · 2001
- Descendant · 3 generations on · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · 2 generations on · 3 of its ownK052183 Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005
- Descendant · 4 generations on · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K992026Soring GMBH, Sonoca 300Soring GmbH Medizintechnik · 1999 · cites it directly11descendants
- K012753Soring GMBH Sonoca 180/190Soring GmbH Medizintechnik · 2001 · 2 generations on6descendants
- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · 3 generations on5descendants
- K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005 · 2 generations on3descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942095 | Sonoca Iii | Holl Meditronics, Inc. | 1994 | — |
| +1 | K992026 | Soring GMBH, Sonoca 300 | Soring GmbH Medizintechnik | 1999 | — |
| +2 | K012753 | Soring GMBH Sonoca 180/190 | Soring GmbH Medizintechnik | 2001 | — |
| +3 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +2 | K052183 | Soring GMBH Sonoca Lipo | Soring GmbH Medizintechnik | 2005 | — |
| +4 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992026 | Soring GMBH, Sonoca 300 | 1999 | 11 |
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?
- Of its descendants, K992026 (Soring GmbH Medizintechnik, 1999) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K942095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942095: Sonoca Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942095
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026