510(k) · Cleared
ClearedWiltek Papillotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiltek Medical, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Dec 21, 1989 after a 143-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 21, 1989
- Review
- 143 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK894861 Wiltek PapillotomeWiltek Medical, Inc. · 1989
- Descendant · cites it directly · 1 of its ownK982557 Bard Proforma and Apollo Pre-Curved PapillotomesBard Interventional Products Div. · 1998
- Descendant · 2 generations on · 0 of its ownK080946 Conmed Axcess Papillotome Models AX4535, AX4535FXConmed Endoscopic Technologies, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK990376 Ballard Medical Products Faciletome Bow String PapillotomeBallard Medical Products · 1999
- Descendant · cites it directly · 0 of its ownK963484 Bard High Flow PapillotomeBard Interventional Products Div. · 1996
Most influential descendants
Showing 4 of 4 · See all- K982557Bard Proforma and Apollo Pre-Curved PapillotomesBard Interventional Products Div. · 1998 · cites it directly1descendant
- K080946Conmed Axcess Papillotome Models AX4535, AX4535FXConmed Endoscopic Technologies, Inc. · 2008 · 2 generations on0descendants
- K990376Ballard Medical Products Faciletome Bow String PapillotomeBallard Medical Products · 1999 · cites it directly0descendants
- K963484Bard High Flow PapillotomeBard Interventional Products Div. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894861 | Wiltek Papillotome | Wiltek Medical, Inc. | 1989 | — |
| +1 | K982557 | Bard Proforma and Apollo Pre-Curved Papillotomes | Bard Interventional Products Div. | 1998 | — |
| +2 | K080946 | Conmed Axcess Papillotome Models AX4535, AX4535FX | Conmed Endoscopic Technologies, Inc. | 2008 | — |
| +1 | K990376 | Ballard Medical Products Faciletome Bow String Papillotome | Ballard Medical Products | 1999 | — |
| +1 | K963484 | Bard High Flow Papillotome | Bard Interventional Products Div. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2008 | 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? (4)
3 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, K982557 (Bard Interventional Products Div., 1998) has gone furthest, with 1 descendant 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/K894861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K894861: Wiltek Papillotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894861
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026