510(k) · Cleared

Cleared

Avanos* CORTRAK* 2 Enteral Access System (EAS)

K220588510(k) TraditionalCleared Apr 22, 202252-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Avanos Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Apr 22, 2022 as substantially equivalent to K191340 (Avanos Medical, Inc., 2019) after a 52-day review. Its family tree reaches back 2 generations to 2012. 2 of the 3 devices in its family, counting itself, have a Class I recall.

Decided: Apr 22, 2022
Review: 52 days
Class: Class II
Product code: KNT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K113351 (2012). No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK113351 Cortrak Enteral Access DeviceCorpak Medsystems · 2012 · Recalled (Class I)
1 generation backK191340 CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. · 2019 · Recalled (Class I)
This deviceK220588 Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc. · 2022

Class I recalls in this family

K191340 CORTRAK* 2 Equilateral Enteral Access Systemdirect predicate · 2019
K113351 Cortrak Enteral Access Device2 generations back · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K113351	Cortrak Enteral Access Device	Corpak Medsystems	2012	Class I
−1	K191340	CORTRAK* 2 Equilateral Enteral Access System	Avanos Medical, Inc.	2019	Class I
0 (this device)	K220588	Avanos* CORTRAK* 2 Enteral Access System (EAS)	Avanos Medical, Inc.	2022	—

FIG. 1 — Lineage of K220588, 2012–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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

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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	Applicant	Decided	Recalls
*	K191340	CORTRAK* 2 Equilateral Enteral Access System Summary page 4 …21 CFR § 876.5980 Regulatory Class: II FDA Product Code: KNT 3. Predicate Device CORTRAK* 2 Equilateral EAS (K191340) 4. Description of Device Avanos* CORTRAK* 2 Enteral Access System (EAS) device is designed to track the path of an 8 Fr…	Avanos Medical, Inc.	2019	Class I

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K113351Cortrak Enteral Access DeviceCorpak Medsystems · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.4 years on median.
2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · KNT

4in 2025

2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007high 1,901 (2018) · low 300 (2007)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 Avanos* CORTRAK*2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding placement of Avanos Medical CORTRAK*2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K220588 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220588: Avanos* CORTRAK* 2 Enteral Access System (EAS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220588

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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