510(k) · Cleared
ClearedEntarik Feeding Tube System; Entarik Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gravitas Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Mar 24, 2023 as substantially equivalent to K142327 (Art Healthcare, Ltd., 2015) after a 58-day review. Its family tree reaches back 4 generations to 1983. 1 of the 9 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 24, 2023
- Review
- 58 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K831868 (1983). 7 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK831868 Dobbhoff Feeding Tube W/Hydromer LubBiosearch Medical Products, Inc. · 1983
- 3 generations backK112511 Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
- 2 generations backK123555 Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014
- 1 generation backK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
- This deviceK230206 Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK241169 Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024
Class I recalls in this family
- K113351 Cortrak Enteral Access Device2 generations back · 2012
Most influential descendants
Showing 1 of 1 · See all- K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831868 | Dobbhoff Feeding Tube W/Hydromer Lub | Biosearch Medical Products, Inc. | 1983 | — |
| −3 | K112511 | Dobbhoff Dual Port Feeding Tube | Covidien Lp, Formerly Registered AS Kendall | 2012 | — |
| −2 | K123555 | Kangaroo Feeding Tubes with Iris Technology | Covidien | 2014 | — |
| −1 | K142327 | smARTrack Feeding Tube System | Art Healthcare, Ltd. | 2015 | — |
| 0 (this device) | K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023 | — |
| +1 | K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
1 device in this family has 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? (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 | Decided |
|---|---|---|---|
| * | K142327 | smARTrack Feeding Tube SystemSummary page 5…Class II Product Code: KNT Panel: Gastrointestinal and Urology Devices Predicate Device: smARTrack™ Feeding Tube System (K142327) Device Description The Entarik Feeding Tube System (Entarik System) consists of the Entarik Enteral Feeding Tube and the Ent… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241169 | Entarik NI Feeding Tube System | 2024 | 0 |
Has anything in its family been recalled? (1 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.
- K113351Cortrak Enteral Access DeviceCorpak Medsystems · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 40 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- 3 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241169 (Gravitas Medical, Inc., 2024) has gone furthest, with 0 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. 2023, 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 Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into…
Read the full statement (130 words)
The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.
The Entarik Feeding Tube System is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230206: Entarik Feeding Tube System; Entarik Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230206
Report an extraction error
Are you the manufacturer?
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