510(k) · Cleared
Recalled · Class II · 2011Xues-41 Endoscopic Electrosurgical Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Olympus Optical Co. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Mar 24, 2003 as substantially equivalent to K023767 (The Olympus Optical Co., 2002) and 1 other predicate after a 62-day review. Its family tree reaches back 3 generations to 1991. 49 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 24, 2003
- Review
- 62 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K911904 (1991). 9 ancestors in all. 49 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK911904 Models Ues-10 & PSD-10Olympus Corp. · 1991
- 2 generations backK970184 Olympus Ues-20 Electrosurgical System and Its Associated AccessoriesOlympus America, Inc. · 1997
- 1 generation backK023767 Ues-30 Electrosurgical Unit and It's Associated AccessoriesThe Olympus Optical Co. · 2002
- This deviceK030194 Xues-41 Endoscopic Electrosurgical UnitThe Olympus Optical Co. · 2003
- Descendant · cites it directly · 22 of its ownK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- Descendant · 2 generations on · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- Descendant · cites it directly · 15 of its ownK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
- Descendant · cites it directly · 12 of its ownK103032 Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W…Olympus Winter & Ibe GmbH · 2011
- Descendant · 2 generations on · 11 of its ownK141225 Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH · 2014
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010 · cites it directly22descendants
- K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · 2 generations on16descendants
- K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH · 2010 · cites it directly15descendants
- K103032Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal…Olympus Winter & Ibe GmbH · 2011 · cites it directly12descendants
- K141225Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-CordOlympus Winter & Ibe GmbH · 2014 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911904 | Models Ues-10 & PSD-10 | Olympus Corp. | 1991 | — |
| −2 | K970184 | Olympus Ues-20 Electrosurgical System and Its Associated Accessories | Olympus America, Inc. | 1997 | — |
| −1 | K023767 | Ues-30 Electrosurgical Unit and It's Associated Accessories | The Olympus Optical Co. | 2002 | — |
| 0 (this device) | K030194 | Xues-41 Endoscopic Electrosurgical Unit | The Olympus Optical Co. | 2003 | — |
| +1 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| +2 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| +1 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| +1 | K103032 | Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch… | Olympus Winter & Ibe GmbH | 2011 | — |
| +2 | K141225 | Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord | Olympus Winter & Ibe GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K023767 | Ues-30 Electrosurgical Unit and It's Associated AccessoriesSummary page 3…ancillary equipment. F. Reason for Not Requiring Clinical Data The subject XUES-41 is similar to the OLYMPUS UES-30 Electrosurgical UNIT cleared in the previous 510(k) #K023767, Gyrus cleared in the previous 510(k) #990628.And when compared to the predicated devices listed above, the Olympus XUES-41 Elect… | 2002 |
| * | K990628 | Gyrus Endourology SystemSummary page 3…ng Clinical Data The subject XUES-41 is similar to the OLYMPUS UES-30 Electrosurgical UNIT cleared in the previous 510(k) #K023767, Gyrus cleared in the previous 510(k) #990628.And when compared to the predicated devices listed above, the Olympus XUES-41 Electrosurgical UNIT does not incorporate any signi… | 1999 |
What descends from it? (49)
See all 494 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100816 | PK Superpulse Sysem Generator Model 744000 | 2010 | 22 |
| K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection… | 2010 | 15 |
| K103032 | Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal… | 2011 | 12 |
| K042274 | PSD-60/Endoplasma | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 27, 2011 | Not classified | Z-0829-2012 | Component design/selection | Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements |
| Dec 27, 2011 | Not classified | Z-0828-2012 | Component design/selection | Less than optimal thickness in the plastic housing holding the electrode in the Olympus Working Elements |
| Nov 10, 2009 | Class II | Z-1277-2013 | Use error | Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K100816 (Gyrus Acmi, Inc., 2010) has gone furthest, with 22 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
This instrument has been designed for use in a medical facility under the supervision of a
trained physician. It has been designed for general(open) and endoscopic surgery including
urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed
electrosurgical accessories, endoscopes(fiberscopes, videoscopes and rigid scopes)
applicable for electrosurgery(cutting and coagulation), light sources and other ancillary
equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030194: Xues-41 Endoscopic Electrosurgical Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030194
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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