510(k) · Cleared
ClearedModification to Cortrak Enteral Access Device, Model 20-0900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Medsystems · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 27, 2008 after a 109-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 109 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK080679 Modification to Cortrak Enteral Access Device, Model 20-0900Viasys Medsystems · 2008
- Descendant · cites it directly · 2 of its ownK182915 ENvizion Medical ENvue; ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK191387 ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK203133 ENvizion Medical ENvue ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019 · cites it directly2descendants
- K191387ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019 · 2 generations on1descendant
- K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080679 | Modification to Cortrak Enteral Access Device, Model 20-0900 | Viasys Medsystems | 2008 | — |
| +1 | K182915 | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube | Envizion Medical, Ltd. | 2019 | — |
| +2 | K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube | Envizion Medical, Ltd. | 2019 | — |
| +3 | K203133 | ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube | Envizion Medical, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182915 | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube | 2019 | 2 |
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, K182915 (Envizion Medical, Ltd., 2019) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The CORTRAK™ System is an electrical device designed to aid qualified operators in the placement of VIASYS MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. Prior to commencing the delivery of food, confirmation of correct tube placement by acceptable hospital protocol is required.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080679 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080679: Modification to Cortrak Enteral Access Device, Model 20-0900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080679
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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