510(k) Report

510(k) · Cleared

Cleared

Cusa System 200C,T & M Ultrasonic Surgical Aspira.

K884412510(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. 7 later devices descend from it.

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

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK884412 Cusa System 200C,T & M Ultrasonic Surgical Aspira.Valleylab, Inc. · 1988
  2. Descendant · cites it directly · 6 of its ownK990572 SonotomeSonokinetics, Inc. · 1999
  3. Descendant · 2 generations on · 4 of its ownK152699 Apollo SystemPenumbra, Inc. · 2016
  4. Descendant · 3 generations on · 2 of its ownK171332 Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017
  5. Descendant · 4 generations on · 1 of its ownK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
  6. Descendant · 5 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

1999: 22016: 12017: 12018: 12020: 12023: 1
1999high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 7 · See all
  • K990572SonotomeSonokinetics, Inc. · 1999 · cites it directly6descendants
  • K152699Apollo SystemPenumbra, Inc. · 2016 · 2 generations on4descendants
  • K171332Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017 · 3 generations on2descendants
  • K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020 · 4 generations on1descendant
  • K230125Neuroblade SystemClearmind Biomedical · 2023 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884412Cusa System 200C,T & M Ultrasonic Surgical Aspira.Valleylab, Inc.1988—
+1K990572SonotomeSonokinetics, Inc.1999—
+2K152699Apollo SystemPenumbra, Inc.2016—
+3K171332Artemis Neuro Evacuation DevicePenumbra, Inc.2017—
+4K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical2020—
+5K230125Neuroblade SystemClearmind Biomedical2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
201610
201710
201810
202010
202310
FIG. 1 — Lineage of K884412, 1988–2023Source: 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
Get a 510(k) Report

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? (7)

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

NumberDeviceApplicantDecidedDescendants
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, K990572 (Sonokinetics, Inc., 1999) has gone furthest, with 6 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
  • K884413Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
  • K883522Amerimed Ultrasonic Surgical Aspiration KitAmerimed US Corp. · 1988
  • K855138Bovie Ultrasonic Surgical SystemClinical Technology Corp. · 1986

https://510kreport.com/device/K884412 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884412: Cusa System 200C,T & M Ultrasonic Surgical Aspira..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884412

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026