510(k) · Cleared
ClearedMentor Ultrasound Assisted Tissue Removal System (TRS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · LFL Instrument, Ultrasonic Surgical
Cleared on Jul 17, 1997 as substantially equivalent to K962525 (Morwel Corp., 1996) and 1 other predicate after a 160-day review. Its family tree reaches back 1 generation to 1991. 52 later devices descend from it.
- Decided
- Jul 17, 1997
- Review
- 160 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910696 (1991). 2 ancestors in all. 52 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
- This deviceK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
- Descendant · cites it directly · 49 of its ownK004005 Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor…Mentor Corp. · 2001
- Descendant · cites it directly · 49 of its ownK983065 Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998
- Descendant · cites it directly · 48 of its ownK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- Descendant · 2 generations on · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- Descendant · 3 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K004005Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis…Mentor Corp. · 2001 · cites it directly49descendants
- K983065Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998 · cites it directly49descendants
- K022051Soundvaser SystemSound Surgical Technologies, LLC · 2002 · cites it directly48descendants
- K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · 2 generations on36descendants
- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 3 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra Aspirator | Valleylab, Inc. | 1991 | — |
| 0 (this device) | K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS) | Mentor Corp. | 1997 | — |
| +1 | K004005 | Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour… | Mentor Corp. | 2001 | — |
| +1 | K983065 | Mentor Ultrasound-Assisted Tissue Removal System | Mentor Corp. | 1998 | — |
| +1 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| +2 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| +3 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962525 | Ultra-Safe Ultrasonic Aspirator SystemSummary page 2…antially equivalent to pre-amendment devices as outlined in the following table: Table 1 Manufacturer Product 510(k) Number Morwel Corporation Ultra-Safe Ultrasonic K962525 Aspiration System Valleylab Valleylab CUSA System K910696 000014 - HEALTY ~‘\«° 4, ERVIC, .8 £S5 Yy, %, ¥vaaq… | 1996 |
| * | K910696 | Cusa (R) System 200C/200T/200M/200H Ultra AspiratorSummary page 2…n the following table: Table 1 Manufacturer Product 510(k) Number Morwel Corporation Ultra-Safe Ultrasonic K962525 Aspiration System Valleylab Valleylab CUSA System K910696 000014 - HEALTY ~‘\«° 4, ERVIC, .8 £S5 Yy, %, ¥vaaq (C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health S… | 1991 |
What descends from it? (52)
See all 524 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?
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 Mentor Ultrasound Assisted Tissue Removal System is indicated for use for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications.
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/K970471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970471: Mentor Ultrasound Assisted Tissue Removal System (TRS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970471
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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