510(k) · Cleared
ClearedOlympus KD Series Sphincterotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Apr 30, 1996 after a 167-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Apr 30, 1996
- Review
- 167 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK955247 Olympus KD Series SphincterotomeOlympus America, Inc. · 1996
- Descendant · cites it directly · 4 of its ownK971328 Olympus CD-6C-1 Coagulation ElectrodeOlympus America, Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK120909 EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 2012
- Descendant · 3 generations on · 1 of its ownK183240 Empower RF CatheterBroncus Medical, Inc. · 2019
- Descendant · 4 generations on · 0 of its ownK200702 EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK170296 CoreCath 2.7SMedtronic Advanced Energy · 2017
Most influential descendants
Showing 5 of 5 · See all- K971328Olympus CD-6C-1 Coagulation ElectrodeOlympus America, Inc. · 1997 · cites it directly4descendants
- K120909EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 2012 · 2 generations on3descendants
- K183240Empower RF CatheterBroncus Medical, Inc. · 2019 · 3 generations on1descendant
- K200702EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021 · 4 generations on0descendants
- K170296CoreCath 2.7SMedtronic Advanced Energy · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955247 | Olympus KD Series Sphincterotome | Olympus America, Inc. | 1996 | — |
| +1 | K971328 | Olympus CD-6C-1 Coagulation Electrode | Olympus America, Inc. | 1997 | — |
| +2 | K120909 | EC 2.7 Endoscopic Cutter | Medtronic Advanced Energy, LLC | 2012 | — |
| +3 | K183240 | Empower RF Catheter | Broncus Medical, Inc. | 2019 | — |
| +4 | K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | 2021 | — |
| +3 | K170296 | CoreCath 2.7S | Medtronic Advanced Energy | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | — | Olympus KD-1/2 pre-Amendment Diathermic Cutters Named without a submission number | |
| * | — | Olympus PK Papillotomy Knives Named without a submission number | |
| * | — | Olympus KD-6G Sphincterotomes Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971328 | Olympus CD-6C-1 Coagulation Electrode | 1997 | 4 |
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, K971328 (Olympus America, Inc., 1997) has gone furthest, with 4 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?
The KD sphincterotomes and the predicated devices are all designed specifically to perform endoscopic sphincterotomy of the papilla of Vater
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955247 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955247: Olympus KD Series Sphincterotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955247
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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