510(k) · Cleared
ClearedCook Ireland Duette Multi-Band Mucosectomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ireland, Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Apr 22, 2005 as substantially equivalent to K984358 (Olympus America, Inc., 1999) after a 46-day review. Its family tree reaches back 3 generations to 1986. 4 later devices descend from it.
- Decided
- Apr 22, 2005
- Review
- 46 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K853585 (1986). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- This deviceK050578 Cook Ireland Duette Multi-Band Mucosectomy DeviceCook Ireland, Ltd. · 2005
- Descendant · cites it directly · 2 of its ownK140726 Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator…Boston Scientific Corp · 2014
- Descendant · 2 generations on · 1 of its ownK190512 SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareIntelligent Endoscopy · 2019
- Descendant · 3 generations on · 0 of its ownK212860 SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand…STERIS Corporation · 2021
- Descendant · cites it directly · 0 of its ownK103155 Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K140726Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device for…Boston Scientific Corp · 2014 · cites it directly2descendants
- K190512SmartBand EMR Kit, SmartBand EMR Pack, SmartSnareIntelligent Endoscopy · 2019 · 2 generations on1descendant
- K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…STERIS Corporation · 2021 · 3 generations on0descendants
- K103155Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| 0 (this device) | K050578 | Cook Ireland Duette Multi-Band Mucosectomy Device | Cook Ireland, Ltd. | 2005 | — |
| +1 | K140726 | Captivator Emr Device for Standard Gastroscopes - Box 1, Captivator Emr Device… | Boston Scientific Corp | 2014 | — |
| +2 | K190512 | SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare | Intelligent Endoscopy | 2019 | — |
| +3 | K212860 | SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack… | STERIS Corporation | 2021 | — |
| +1 | K103155 | Sumo Access and Tissue Resection System | Apollo Endosurgery, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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? (1)
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 |
|---|---|---|---|
| * | K984358 | Olympus Distal Attachment, Models…Summary page 1…vice: Olympus Distal Attachment (MH and MAJ models) for Endoscopic Mucosal Resection, K984358 Intended Use: -The Duette TM Multi-Band Mucosectomy Device is intended for… | 1999 |
What descends from it? (4)
2 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K140726 (Boston Scientific Corp, 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K984358.
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 Duette TM Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050578: Cook Ireland Duette Multi-Band Mucosectomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050578
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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