510(k) · Cleared
ClearedElectrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Endosurgery, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Dec 19, 2008 as substantially equivalent to K993720 (Cordis Corp., 2000) and 2 other predicates after a 144-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Dec 19, 2008
- Review
- 144 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K993720 (2000). 6 ancestors in all, the oldest K970053 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK993720 Cordis Maxi LD Large Diameter Balloon Dilatation CatheterCordis Corp. · 2000
- 1 generation backK023907 Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis…Cordis Corp. · 2002
- This deviceK082114 Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00…Apollo Endosurgery, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK103155 Sumo Access and Tissue Resection SystemApollo Endosurgery, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK093279 Navix Access DeviceXlumena · 2010 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993720 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter | Cordis Corp. | 2000 | — |
| −1 | K023907 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta… | Cordis Corp. | 2002 | — |
| 0 (this device) | K082114 | Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00 | Apollo Endosurgery, Inc. | 2008 | — |
| +1 | K103155 | Sumo Access and Tissue Resection System | Apollo Endosurgery, Inc. | 2011 | — |
| +1 | K093279 | Navix Access Device | Xlumena | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K993720 | Cordis Maxi LD Large Diameter Balloon Dilatation CatheterSummary page 1…gus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. Predicate Devices K993720 Cordis Maxi LD Dilation Balloon Cordis K023907 Cordis Maxi LD Dilation Balloon Cordis K… | 2000 |
| * | K023907 | Cordis Maxi LD Large Diameter Balloon Dilatation Catheter, Cordis Maxi LD Pta Balloon…Summary page 1…uterizing soft tissue during endoscopic electrosurgical procedures. Predicate Devices K993720 Cordis Maxi LD Dilation Balloon Cordis K023907 Cordis Maxi LD Dilation Balloon Cordis K073046 Endo Surgery Needle Knife Ethicon Devic… | 2002 |
| * | K073046 | Ethicon Endo Surgery Articulating Needle Knife, Model 2504Summary page 1…dures. Predicate Devices K993720 Cordis Maxi LD Dilation Balloon Cordis K023907 Cordis Maxi LD Dilation Balloon Cordis K073046 Endo Surgery Needle Knife Ethicon Device Description The Electrocautery Dilation Balloon is indicat… | 2008 |
What descends from it? (2)
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 8 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K103155 (Apollo Endosurgery, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K993720.
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. 2008, this device’s year, is highlighted.
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 Electrocautery Dilation Balloon is intended for dilation of strictures of the esophagus and gastrointestinal tract and cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082114: Electrocautery Dilation Balloon, Models: Edb-0018-00, Edb-0020-00, Edb-0022-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082114
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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