510(k) Report

510(k) · Cleared

Cleared

Soring GMBH Sonoca Lipo

K052183510(k) TraditionalCleared Oct 7, 200558-day reviewClass II21 CFR 878.5040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Soring GmbH Medizintechnik · QPB System, Suction, Lipoplasty For Removal

Cleared on Oct 7, 2005 as substantially equivalent to K992026 (Soring GmbH Medizintechnik, 1999) and 1 other predicate after a 58-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it.

Decided
Oct 7, 2005
Review
58 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K910696 (1991). 22 ancestors in all, the oldest K884413 (1988). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 4 other ancestors2001: 1 other ancestor1994: 2 other ancestors1998: 2 other ancestors1997: 2 other ancestors1996: 2 other ancestors1992: 1 other ancestor1995: 2 other ancestors1988: 1 other ancestor2010: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant clearedK910696 · Cusa (R) System 200C/200T/200M/200H Ultra Aspirator · Valleylab, Inc. · 1991K970471 · Mentor Ultrasound Assisted Tissue Removal System (TRS) · Mentor Corp. · 1997K983065 · Mentor Ultrasound-Assisted Tissue Removal System · Mentor Corp. · 1998K022051 · Soundvaser System · Sound Surgical Technologies, LLC · 2002 · recalledK041058 · Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems · Misonix, Inc. · 2004 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 8 other ancestors5 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K041058 · Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems · Misonix, Inc. · 2004 · recalledK022051 · Soundvaser System · Sound Surgical Technologies, LLC · 2002 · recalledK983065 · Mentor Ultrasound-Assisted Tissue Removal System · Mentor Corp. · 1998K970471 · Mentor Ultrasound Assisted Tissue Removal System (TRS) · Mentor Corp. · 1997K910696 · Cusa (R) System 200C/200T/200M/200H Ultra Aspirator · Valleylab, Inc. · 1991−50
  1. Root · 5 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
  2. 4 generations backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
  3. 3 generations backK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
  4. 2 generations backK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
  5. 1 generation backK041058 Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc. · 2004 · Recalled
  6. This deviceK052183 Soring GMBH Sonoca LipoSoring GmbH Medizintechnik · 2005
  7. Descendant · cites it directly · 2 of its ownK092066 Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01)…Andrew Technologies, LLC · 2010
  8. Descendant · 2 generations on · 1 of its ownK121218 Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia…Andrew Technologies, LLC · 2012
  9. Descendant · 3 generations on · 0 of its ownK130152 Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013

Most influential descendants

Showing 3 of 3 · See all
  • K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC · 2010 · cites it directly2descendants
  • K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM Length, 3…Andrew Technologies, LLC · 2012 · 2 generations on1descendant
  • K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC · 2013 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K910696Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc.1991—
−4K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp.1997—
−3K983065Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp.1998—
−2K022051Soundvaser SystemSound Surgical Technologies, LLC20022
−1K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator SystemsMisonix, Inc.20041
0 (this device)K052183Soring GMBH Sonoca LipoSoring GmbH Medizintechnik2005—
+1K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser…Andrew Technologies, LLC2010—
+2K121218Hydrasolve Console Sterile Treatment Kit Reusable Cannula, 4MM Dia, 26 CM…Andrew Technologies, LLC2012—
+3K130152Hydrasolve Lipoplasty SystemAndrew Technologies, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199210
199420
199520
199620
199720
199820
199940
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
FIG. 1 — Lineage of K052183, 1991–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 QPB? 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 QPB device

  1. #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K992026Soring GMBH, Sonoca 300
Summary page 5
…LIPOPLASTY POWERED) REGULATIO NUMBER4780 85040 510(K) NUMBER K992026 K041058 MISONIX INC. LYSONIX DEVICE…
Soring GmbH Medizintechnik1999—
*K041058Misonix Inc. Lysonix 2000/3000 Ultrasonic Surgical Aspirator Systems
Summary page 5
…POWERED) REGULATIO NUMBER4780 85040 510(K) NUMBER K992026 K041058 MISONIX INC. LYSONIX DEVICE NAME SRN…
Misonix, Inc.20041

Also cleared against K992026: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102

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 5 companies; a new generation was cleared every 1.7 years on median.
  • 5 of the 22 ancestors have a recall of any class.
  • Of its descendants, K092066 (Andrew Technologies, LLC, 2010) has gone furthest, with 2 descendants of its own.
  • 1 other device also cites its predicate K992026.

How does its category compare?

All QPB devices

QPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QPB

5so far in 2026, the most since 2007

2007: 22008: 42009: 12010: 22011: 22012: 32014: 12015: 12016: 12017: 32019: 22020: 22022: 22024: 42025: 22026 (partial year): 5
2007high 5 (2026) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QPB

194in 2024

2008: 69 days median2012: 234 days median2017: 112 days median2024: 194 days median2026 (partial year): 238 days median
2007high 238 (2026) · low 69 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QPB

No recall names QPB since 2007.

Adverse event reports per year · QPB

16in 2025

2022: 52023: 282024: 162025: 16
2007high 28 (2023) · low 0 (2007)2025

MAUDE reports naming product code QPB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200846900
20091—00
20102—00
20112—00
2012323400
20130—00
20141—00
20151—00
20161—00
2017311200
20180—00
20192—00
20202—00
20210—00
20222—05
20230—028
20244194016
20252—016
202652380—

What is it indicated for?

The SONOCA Lipo is an instrument indicated for selected ultrasound dissection, liquefaction, emulsifying and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery, and Gynecological Surgery applications. It is also indicated for the liquefaction and aspiration of localized subcutaneous fatty tissue for aesthetic body contouring.

Typical users of this system are trained medical professionals.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K052183: Soring GMBH Sonoca Lipo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052183

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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