510(k) Report

510(k) · Cleared

Cleared

Lithovac Suction/Aspiration Probe

K964111510(k) TraditionalCleared Dec 16, 199662-day reviewClass II21 CFR 876.4370

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

Electro Medical Systems SA · KQT Evacuator, Gastro-Urology

Cleared on Dec 16, 1996 after a 62-day review. The FDA summary names its predicate without a number.

Decided
Dec 16, 1996
Review
62 days
Class
Class II
Product code
KQT
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K964111Source: FDA 510(k) database · 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 KQT? 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? (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
*—Uromat Suction Pump/Calcuson Ultrasonic Lithotrite System
Named without a submission number
—
*—Olympus Ureteromat Pump/LUS Lithotripsy device
Named without a submission number
—
*—Corson Disposable Suction Irrigation Probe
Named without a submission number
—
*—Nezhat-Dorsey Hydro-Dissection Reusable Suction Irrigation Probe
Named without a submission number
—

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.

How does its category compare?

All KQT devices

KQT Evacuator, Gastro-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KQT

FDA has decided no KQT device since 2007.

Median 510(k) review, days · KQT

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

Recalls per year · KQT

4so far in 2026, the most since 2007

2011: 12026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

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

Adverse event reports per year · KQT

12in 2025

2007: 82008: 62009: 202010: 12011: 22013: 22014: 12017: 62018: 102019: 42020: 162021: 112022: 82023: 42024: 62025: 12
2007high 20 (2009) · low 0 (2012)2025

MAUDE reports naming product code KQT, 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—08
20080—06
20090—020
20100—01
20110—12
20120—00
20130—02
20140—01
20150—00
20160—00
20170—06
20180—010
20190—04
20200—016
20210—011
20220—08
20230—04
20240—06
20250—012
20260—4—

What is it indicated for?

The Electro Medical Systems SA LITHOVAC Suction/Aspiration Probe is designed for the suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes. It can be used alone, or it can be used during and after fragmentation of urinary tract calculi with the EMS Swiss LITHOCLAST intracorporeal lithotripter. It is specifically designed so that an EMS LITHOCLAST lithotripsy probe can be inserted through the LITHOVAC suction tube so that stone fragments and debris can be aspirated through the LITHOVAC suction tube simultaneously with lithotripsy.

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

More from Electro Medical Systems SA

9 FDA decisions under this applicant name. See the company

  • K022328Ems Piezon Master 600Electro Medical Systems SA · 2002
  • K022119Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
  • K012445Ems Swiss Lithoclast Master (a.K.a. Swiss Lithoclast Ultra)Electro Medical Systems SA · 20013 recalls
  • K002484Ems Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalElectro Medical Systems SA · 2000
  • K992251Swiss Lithoclast Multipurpose ProbeElectro Medical Systems SA · 1999

Recent decisions in KQT

The KQT category page

  • K921088Evacuator, Gastro-UrologyNorthgate Technologies, Inc. · 1992
  • K921451Evacuator, Gastro-UrologyNorthgate Technologies, Inc. · 19921 recall
  • K910728Cleanflow SystemMitron Technologies, Inc. · 1991
  • K880099Van-Tec Bladder EvacuatorVan-Tec, Inc. · 19881 recall
  • K874493Bella - Vac IrrigatorBel-Can Industries · 1988

https://510kreport.com/device/K964111 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964111: Lithovac Suction/Aspiration Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964111

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026