510(k) Report

510(k) · Cleared

Cleared

Cusa System 200H Ultrasonic Surgical Aspirator

K884413510(k) TraditionalCleared Dec 2, 198843-day reviewClass U

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

Valleylab, Inc. · LBK Neurosurgical Ultrasonic Instruments

Cleared on Dec 2, 1988 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 96 later devices descend from it.

Decided
Dec 2, 1988
Review
43 days
Class
Class U
Product code
LBK
Recalls
None
Predicates
0

96 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1999: 3 descendants cleared2005: 2 descendants cleared2011: 3 descendants cleared2002: 2 descendants cleared2009: 3 descendants cleared2003: 1 descendant cleared2014: 6 descendants cleared2004: 4 descendants cleared2016: 4 descendants cleared2008: 2 descendants cleared2007: 3 descendants cleared2010: 6 descendants cleared2006: 1 descendant cleared2019: 6 descendants cleared2018: 4 descendants cleared2015: 3 descendants cleared2022: 5 descendants cleared2017: 7 descendants cleared2012: 8 descendants cleared2021: 5 descendants cleared2013: 2 descendants cleared2020: 4 descendants cleared2024: 3 descendants cleared2025: 2 descendants cleared2023: 3 descendants cleared2026: 3 descendants cleared1990200020102020
  1. This deviceK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
  2. Descendant · cites it directly · 89 of its ownK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
  3. Descendant · 2 generations on · 49 of its ownK991791 Sound Vaser SystemSound Surgical Technologies, LLC · 1999 · Recalled
  4. Descendant · 3 generations on · 48 of its ownK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
  5. Descendant · 4 generations on · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
  6. Descendant · 5 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

1998: 11999: 32002: 22003: 12004: 42005: 22006: 12007: 32008: 22009: 32010: 62011: 32012: 82013: 22014: 62015: 32016: 42017: 72018: 42019: 62020: 42021: 52022: 52023: 32024: 32025: 22026: 3
1998high 8 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 96 · See all
  • K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · cites it directly89descendants
  • K991791Sound Vaser SystemSound Surgical Technologies, LLC · 1999 · 2 generations on49descendants
  • K022051Soundvaser SystemSound Surgical Technologies, LLC · 2002 · 3 generations on48descendants
  • K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · 4 generations on36descendants
  • K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 5 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884413Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc.1988—
+1K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc.19983
+2K991791Sound Vaser SystemSound Surgical Technologies, LLC19992
+3K022051Soundvaser SystemSound Surgical Technologies, LLC20022
+4K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc.2004—
+5K072587Cytori Aft SystemCytori Therapeutics, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199930
200220
200310
200440
200520
200610
200730
200820
200930
201060
201130
201280
201320
201460
201530
201640
201770
201840
201960
202040
202150
202250
202330
202430
202520
202630
FIG. 1 — Lineage of K884413, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 LBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (96)

See all 96

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981262Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc.199889
K990572SonotomeSonokinetics, Inc.19996
K993628Omnisonics Ultrasonic ProbesOmnisonics Medical Technologies19990

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, K981262 (Valleylab, Inc., 1998) has gone furthest, with 89 descendants of its own.

How does its category compare?

All LBK devices

LBK Neurosurgical Ultrasonic Instruments: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LBK

FDA has decided no LBK device since 2007.

Median 510(k) review, days · LBK

Too few LBK 510(k)s in any year since 2007 to give a median.

Recalls per year · LBK

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · LBK

2in 2025

2007: 32008: 12012: 42013: 162014: 92019: 42025: 2
2007high 16 (2013) · low 0 (2009)2025

MAUDE reports naming product code LBK, 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
20070—03
20080—01
20090—00
20100—00
20110—00
20120—04
20130—116
20140—09
20150—00
20160—00
20170—00
20180—00
20190—04
20200—00
20210—00
20220—00
20230—00
20240—00
20250—02
20260—0—

More from Valleylab, Inc.

94 FDA decisions under this applicant name. See the company

  • K031011Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500Valleylab, Inc. · 20032 recalls
  • K010010Valleylab Ligasure Precise Instrument Vessel Sealing System-Model # LS1200 & Sligaure GeneratorValleylab, Inc. · 2001
  • K010013Ligasure Laparoscopic Sealer Divider Model LS1100Valleylab, Inc. · 20012 recalls
  • K994428E7512 Premie Rem Polyhesive II Patient Return ElectrodeValleylab, Inc. · 2000
  • K983743Bisure Laparoscopic Bipolar ForcepsValleylab, Inc. · 1999

Recent decisions in LBK

The LBK category page

  • K972612Dissectron Portable UnitSatelec · 1997
  • K962952Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
  • K884412Cusa System 200C,T & M Ultrasonic Surgical Aspira.Valleylab, Inc. · 1988
  • K883522Amerimed Ultrasonic Surgical Aspiration KitAmerimed US Corp. · 1988
  • K855138Bovie Ultrasonic Surgical SystemClinical Technology Corp. · 1986

https://510kreport.com/device/K884413 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884413: Cusa System 200H Ultrasonic Surgical Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884413

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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