510(k) · Cleared
ClearedPlasmakinetic Endourology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Medical, Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Dec 19, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 59 later devices descend from it.
- Decided
- Dec 19, 2000
- Review
- 29 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
59 later devices descend from it, 2 citing it directly.
- This deviceK003569 Plasmakinetic Endourology SystemGyrus Medical, Ltd. · 2000
- Descendant · cites it directly · 57 of its ownK031085 Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Gyrus Medical, Inc. · 2003
- Descendant · 2 generations on · 23 of its ownK082054 Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and…Gyrus Acmi, Inc. · 2008
- Descendant · 2 generations on · 22 of its ownK100816 PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010
- Descendant · 3 generations on · 16 of its ownK110268 Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011
- Descendant · 2 generations on · 15 of its ownK100275 Working Element, Resection Button Electrode for Plasma Vaporizaton…Olympus Winter & Ibe GmbH · 2010 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K031085Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Gyrus Medical, Inc. · 2003 · cites it directly57descendants
- K082054Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch…Gyrus Acmi, Inc. · 2008 · 2 generations on23descendants
- K100816PK Superpulse Sysem Generator Model 744000Gyrus Acmi, Inc. · 2010 · 2 generations on22descendants
- K110268Forcetriad Electrosurgical GeneratorCovidien Lp, Formerly Know AS Valleylab, A Divison · 2011 · 3 generations on16descendants
- K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH · 2010 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003569 | Plasmakinetic Endourology System | Gyrus Medical, Ltd. | 2000 | — |
| +1 | K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories) | Gyrus Medical, Inc. | 2003 | — |
| +2 | K082054 | Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual… | Gyrus Acmi, Inc. | 2008 | — |
| +2 | K100816 | PK Superpulse Sysem Generator Model 744000 | Gyrus Acmi, Inc. | 2010 | — |
| +3 | K110268 | Forcetriad Electrosurgical Generator | Covidien Lp, Formerly Know AS Valleylab, A Divison | 2011 | — |
| +2 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (59)
See all 592 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031085 (Gyrus Medical, Inc., 2003) has gone furthest, with 57 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 | — |
https://510kreport.com/device/K003569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K003569: Plasmakinetic Endourology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003569
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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