510(k) · Cleared
ClearedResectoscope Loops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Oct 1, 1990 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Oct 1, 1990
- Review
- 68 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 4 citing it directly.
- This deviceK903323 Resectoscope LoopsOlympus Corp. · 1990
- 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 · 5 of its ownK152092 Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK102781 Resection Button Electrode for Plasma Vaporization, HF-Resection…Olympus Winter & Ibe GmbH · 2011 · Recalled
- Descendant · cites it directly · 4 of its ownK093181 Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK171965 Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K100275Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection…Olympus Winter & Ibe GmbH · 2010 · cites it directly15descendants
- K152092Resection ElectrodesOlympus Winter & Ibe GmbH · 2015 · cites it directly5descendants
- K102781Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and…Olympus Winter & Ibe GmbH · 2011 · 2 generations on5descendants
- K093181Gyrus Acmi PK Button ElectrodeGyrus Acmi, Inc. · 2010 · cites it directly4descendants
- K171965Resection Electrodes with HF cableOlympus Winter & Ibe GmbH · 2017 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903323 | Resectoscope Loops | Olympus Corp. | 1990 | — |
| +1 | K100275 | Working Element, Resection Button Electrode for Plasma Vaporizaton… | Olympus Winter & Ibe GmbH | 2010 | 1 |
| +1 | K152092 | Resection Electrodes | Olympus Winter & Ibe GmbH | 2015 | 1 |
| +2 | K102781 | Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode… | Olympus Winter & Ibe GmbH | 2011 | 1 |
| +1 | K093181 | Gyrus Acmi PK Button Electrode | Gyrus Acmi, Inc. | 2010 | — |
| +2 | K171965 | Resection Electrodes with HF cable | Olympus Winter & Ibe GmbH | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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? (21)
See all 214 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, K100275 (Olympus Winter & Ibe GmbH, 2010) has gone furthest, with 15 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/K903323 · printed Nov 5, 2026
Cite this page
510(k) Report. “K903323: Resectoscope Loops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903323
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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