510(k) · Cleared

Recalled · Class I · 2022

CORTRAK* 2 Equilateral Enteral Access System

K191340510(k) SpecialCleared Jun 4, 201915-day reviewClass II21 CFR 876.5980Recalls 1 (1 Class I)

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 Jun 4, 2019 as substantially equivalent to K113351 (Corpak Medsystems, 2012) after a 15-day review. Its family tree reaches back 1 generation to 2012. 2 of the 3 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once, including a Class I recall.

Decided: Jun 4, 2019
Review: 15 days
Class: Class II
Product code: KNT
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K113351 (2012). 1 later device descends from it, 1 citing it directly. 2 of the 3 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK113351 Cortrak Enteral Access DeviceCorpak Medsystems · 2012 · Recalled (Class I)
This deviceK191340 CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc. · 2019
Descendant · cites it directly · 0 of its ownK220588 Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc. · 2022

Class I recalls in this family

K113351 Cortrak Enteral Access Devicedirect predicate · 2012

Most influential descendants

Showing 1 of 1 · See all

K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc. · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K191340, 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
*	K113351	Cortrak Enteral Access Device Summary page 4 …FR § 876.5980 FDA Product Code: KNT Regulatory/Device Class: Class II 2. PREDICATE DEVICE CORTRAK 2* Enteral Access Device, (K113351) 3. INDICATIONS FOR USE CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid q…	Corpak Medsystems	2012	Class I

Also cleared against K113351: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K220588	Avanos* CORTRAK* 2 Enteral Access System (EAS)	Avanos Medical, Inc.	2022	0

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.

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

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K220588 (Avanos Medical, Inc., 2022) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K113351.

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. 2019, 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?

CORTRAK* 2 Equilateral Enteral Access System is an electrical device designed to aid qualified operators in the placement of Avanos NG feeding tubes of 8 FR or greater into the stomach or small bowel of patients requiring enteral feeding. CORTRAK* 2 Equilateral Enteral Access System 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 summary.

https://510kreport.com/device/K191340 · printed Nov 5, 2026

Cite this page

510(k) Report. “K191340: CORTRAK* 2 Equilateral Enteral Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191340

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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