510(k) Report

510(k) · Cleared

Cleared

Allegro Ultrasonic Soft Tissue Aspirator

K980895510(k) TraditionalCleared Nov 6, 1998242-day reviewClass U

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

California Institute of Tissue Eng. & Instrumenti · LFL Instrument, Ultrasonic Surgical

Cleared on Nov 6, 1998 as substantially equivalent to K970471 (Mentor Corp., 1997) and 3 other predicates after a 242-day review. Its family tree reaches back 2 generations to 1991.

Decided
Nov 6, 1998
Review
242 days
Class
Class U
Product code
LFL
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K910696 (1991). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestorK910696 · Cusa (R) System 200C/200T/200M/200H Ultra Aspirator · Valleylab, Inc. · 1991K970471 · Mentor Ultrasound Assisted Tissue Removal System (TRS) · Mentor Corp. · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors K970471 · Mentor Ultrasound Assisted Tissue Removal System (TRS) · Mentor Corp. · 1997K910696 · Cusa (R) System 200C/200T/200M/200H Ultra Aspirator · Valleylab, Inc. · 19910
  1. Root · 2 generations backK910696 Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc. · 1991
  2. 1 generation backK970471 Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp. · 1997
  3. This deviceK980895 Allegro Ultrasonic Soft Tissue AspiratorCalifornia Institute of Tissue Eng. & Instrumenti · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K910696Cusa (R) System 200C/200T/200M/200H Ultra AspiratorValleylab, Inc.1991—
−1K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)Mentor Corp.1997—
0 (this device)K980895Allegro Ultrasonic Soft Tissue AspiratorCalifornia Institute of Tissue Eng. & Instrumenti1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
FIG. 1 — Lineage of K980895, 1991–1998Source: 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 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. #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 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? (4)

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
*K970471Mentor Ultrasound Assisted Tissue Removal System (TRS)
Summary page 2
…nd ultrasound which the FDA has determined to be substantially equivalent to pre-amendment devices as depicted below: Mentor Ultrasound Assisted Tissue Removal System (K970471) Valleylab CUSA® System (K910696) SMEI Sculpture (K971609) Ultra-Safe (K962525) Electrical signals generated by CITEI’s device…
Mentor Corp.1997—
*K910696Cusa (R) System 200C/200T/200M/200H Ultra Aspirator
Summary page 2
…etermined to be substantially equivalent to pre-amendment devices as depicted below: Mentor Ultrasound Assisted Tissue Removal System (K970471) Valleylab CUSA® System (K910696) SMEI Sculpture (K971609) Ultra-Safe (K962525) Electrical signals generated by CITEI’s device (sinusoidal amplitude, 37-45 kHz…
Valleylab, Inc.1991—
*K971609Sculpture
Summary page 2
…lly equivalent to pre-amendment devices as depicted below: Mentor Ultrasound Assisted Tissue Removal System (K970471) Valleylab CUSA® System (K910696) SMEI Sculpture (K971609) Ultra-Safe (K962525) Electrical signals generated by CITEI’s device (sinusoidal amplitude, 37-45 kHz) are comparable to the in…
Servizi Medico Estetici Italinai Srl.1997—
*K962525Ultra-Safe Ultrasonic Aspirator System
Summary page 2
…amendment devices as depicted below: Mentor Ultrasound Assisted Tissue Removal System (K970471) Valleylab CUSA® System (K910696) SMEI Sculpture (K971609) Ultra-Safe (K962525) Electrical signals generated by CITEI’s device (sinusoidal amplitude, 37-45 kHz) are comparable to the indicated predicate dev…
Morwel Corp.1996—

Also cleared against K970471: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 3 companies; a new generation was cleared every 6.1 years on median.
  • None of the 4 ancestors has a recall.
  • 3 other devices also cite its predicate K970471.

How does its category compare?

All LFL devices

LFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFL

3in 2025

2007: 72008: 22009: 12010: 22011: 32012: 32013: 52014: 32015: 42016: 52017: 22018: 32019: 42020: 42021: 62022: 82023: 42024: 32025: 32026 (partial year): 3
2007high 8 (2022) · low 1 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFL

176in 2025

2007: 99 days median2011: 241 days median2012: 82 days median2013: 73 days median2014: 136 days median2015: 99 days median2016: 111 days median2018: 66 days median2019: 103 days median2020: 190 days median2021: 83 days median2022: 168 days median2023: 104 days median2024: 158 days median2025: 176 days median2026 (partial year): 99 days median
2007high 241 (2011) · low 66 (2018)2026

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

Recalls per year · LFL

11in 2024

2010: 32011: 22012: 52014: 12015: 12017: 12019: 422021: 12023: 22024: 112026 (partial year): 1
2007high 42 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFL

3,857in 2025

2007: 2,2362008: 1,6782009: 3,3242010: 1,2392011: 1,0532012: 1,4912013: 2,4302014: 4,2602015: 2,7772016: 2,6912017: 3,2672018: 3,4612019: 3,1532020: 2,9342021: 3,2892022: 3,4222023: 4,2152024: 4,0172025: 3,857
2007high 4,260 (2014) · low 1,053 (2011)2025

MAUDE reports naming product code LFL, 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
200779902,236
20082—01,678
20091—03,324
20102—31,239
2011324121,053
201238251,491
201357302,430
2014313614,260
201549912,777
2016511102,691
20172—13,267
201836603,461
20194103423,153
2020419002,934
202168313,289
2022816803,422
2023410424,215
20243158114,017
2025317603,857
20263991—

What is it indicated for?

The Allegro is indicated for use in the following surgical specialties

when the fragmentation, emulsification and aspiration of soft tissue is

desired.

—General Surgery

-Plastic and reconstructive Surgery

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

Also cleared against K970471

3 other devices cite the same predicate.

  • K022051Soundvaser SystemSound Surgical Technologies, LLC · 20022 recalls
  • K004005Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis System (Proposed)Mentor Corp. · 2001
  • K983065Mentor Ultrasound-Assisted Tissue Removal SystemMentor Corp. · 1998

Recent decisions in LFL

The LFL category page

  • K261361TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque…Carl Zeiss Meditec, AG · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
  • K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2025
  • K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced…Shanghai Saints Sages Surgical Co., Ltd. · 2025

https://510kreport.com/device/K980895 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980895: Allegro Ultrasonic Soft Tissue Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980895

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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