510(k) · Cleared
Recalled · 2012Corpak Enteric Feeding Tube W/Guide Tip
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 Jul 13, 1982 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 13, 1982
- Review
- 15 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK821906 Corpak Enteric Feeding Tube W/Guide TipCorpak Medsystems · 1982
- Descendant · cites it directly · 2 of its ownK182915 ENvizion Medical ENvue; ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK202539 Nutriglide (TM) Nasal Feeding TubeApplied Medical Technology, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK191387 ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK241169 Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK202748 Enteral Feeding CatheterMedcaptain Life Science Co., Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019 · cites it directly2descendants
- K202539Nutriglide (TM) Nasal Feeding TubeApplied Medical Technology, Inc. · 2020 · cites it directly1descendant
- K191387ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd. · 2019 · 2 generations on1descendant
- K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024 · 2 generations on0descendants
- K202748Enteral Feeding CatheterMedcaptain Life Science Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821906 | Corpak Enteric Feeding Tube W/Guide Tip | Corpak Medsystems | 1982 | — |
| +1 | K182915 | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube | Envizion Medical, Ltd. | 2019 | — |
| +1 | K202539 | Nutriglide (TM) Nasal Feeding Tube | Applied Medical Technology, Inc. | 2020 | 6 |
| +2 | K191387 | ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube | Envizion Medical, Ltd. | 2019 | — |
| +2 | K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024 | — |
| +1 | K202748 | Enteral Feeding Catheter | Medcaptain Life Science Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 26, 2012 | Not classified | Z-1080-2012 | Mixed-up of materials/components | The wrong size Twoomey adapter was packaged with the Jejunal tube. |
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.
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 | — |
https://510kreport.com/device/K821906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K821906: Corpak Enteric Feeding Tube W/Guide Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K821906
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026