510(k) · Cleared
ClearedSoring GMBH, Sonoca 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soring GmbH Medizintechnik · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Sep 23, 1999 as substantially equivalent to K942095 (Holl Meditronics, Inc., 1994) after a 99-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Sep 23, 1999
- Review
- 99 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942095 (1994). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK942095 Sonoca IiiHoll Meditronics, Inc. · 1994
- This deviceK992026 Soring GMBH, Sonoca 300Soring GmbH Medizintechnik · 1999
- Descendant · cites it directly · 6 of its ownK012753 Soring GMBH Sonoca 180/190Soring GmbH Medizintechnik · 2001
- Descendant · 2 generations on · 5 of its ownK062544 AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · Recalled
- Descendant · cites it directly · 3 of its ownK052183 Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005
- Descendant · 3 generations on · 2 of its ownK112782 Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK092066 Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01)…Andrew Technologies, LLC · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K012753Soring GMBH Sonoca 180/190Soring GmbH Medizintechnik · 2001 · cites it directly6descendants
- K062544AR1000 Ultrasonic Wound Therapy SystemArobella Medical, LLC · 2007 · 2 generations on5descendants
- K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005 · cites it directly3descendants
- K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011 · 3 generations on2descendants
- K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942095 | Sonoca Iii | Holl Meditronics, Inc. | 1994 | — |
| 0 (this device) | K992026 | Soring GMBH, Sonoca 300 | Soring GmbH Medizintechnik | 1999 | — |
| +1 | K012753 | Soring GMBH Sonoca 180/190 | Soring GmbH Medizintechnik | 2001 | — |
| +2 | K062544 | AR1000 Ultrasonic Wound Therapy System | Arobella Medical, LLC | 2007 | 1 |
| +1 | K052183 | Soring GMBH Sonoca Lipo | Soring GmbH Medizintechnik | 2005 | — |
| +3 | K112782 | Misonix Sonicone (R) Ultrasonic Wound Care System and Accessories | Misonix, Inc. | 2011 | — |
| +2 | K092066 | Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser… | Andrew Technologies, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 BTA? 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 BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 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 |
|---|---|---|---|
| * | K942095 | Sonoca IiiSummary page 1…e Name: Sonoca 300 Common Name: Instrument, Ultrasonic Surgical Classification Name: General & Plastic Surgery Predicate Device: Applicant: Soéring GmbH 510(k) Number: K942095 Device: Sonoca lli Device Description: SONOCA 300 is an upgraded version of the SONOCA Il having K9942095. During the use of an… | 1994 |
What descends from it? (11)
See all 112 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?
- Its one ancestor has no recall.
- Of its descendants, K012753 (Soring GmbH Medizintechnik, 2001) has gone furthest, with 6 descendants of its own.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | 1 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.
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/K992026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992026: Soring GMBH, Sonoca 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992026
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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