510(k) · Cleared
Recalled · Class I · 2022Cortrak Enteral Access Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corpak Medsystems · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jan 10, 2012 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 6 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jan 10, 2012
- Review
- 57 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 1 (1 Class I)
- Predicates
- 0
5 later devices descend from it, 2 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.
- This deviceK113351 Cortrak Enteral Access DeviceCorpak Medsystems · 2012
- Descendant · cites it directly · 2 of its ownK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK230206 Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK191340 CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. · 2019 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK241169 Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK220588 Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc. · 2022
Class I recalls in this family
- K191340 CORTRAK* 2 Equilateral Enteral Access Systemcites it directly · 2019
Most influential descendants
Showing 5 of 5 · See all- K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015 · cites it directly2descendants
- K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023 · 2 generations on1descendant
- K191340CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. · 2019 · cites it directly1descendant
- K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024 · 3 generations on0descendants
- K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113351 | Cortrak Enteral Access Device | Corpak Medsystems | 2012 | — |
| +1 | K142327 | smARTrack Feeding Tube System | Art Healthcare, Ltd. | 2015 | — |
| +2 | K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023 | — |
| +1 | K191340 | CORTRAK* 2 Equilateral Enteral Access System | Avanos Medical, Inc. | 2019 | Class I |
| +3 | K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024 | — |
| +2 | K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | Avanos Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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.
2 devices in this family have a Class I recall. 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? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2022 | Class I | Z-1032-2022 | Device Design | Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K191340CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K142327 (Art Healthcare, Ltd., 2015) 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. 2012, 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 CORTHAK 2 System is an electrical device designed to aid qualified operators in the placement of the CORPAK MedSystems feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK 2 can be used to confirm placement of feeding tubes prior to commencing the delivery of enteral nutrition.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113351: Cortrak Enteral Access Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113351
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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