510(k) · Decided
Recalled · Class I · 2024Mic Gastro-Enterostomy Tube Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Innovations Corp. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 2, 1994 after a 773-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 12 devices in its family, counting itself, has a Class I recall. 11 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- May 2, 1994
- Review
- 773 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 2 (2 Class I)
- Predicates
- 0
11 later devices descend from it, 1 citing it directly. 1 of the 12 devices in this family, counting this one, has a Class I recall.
- This deviceK921370 Mic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. · 1994
- Descendant · cites it directly · 10 of its ownK080253 Kimberly-Clark Introducer KitsKimberly-Clark Corp. · 2008
- Descendant · 2 generations on · 5 of its ownK093312 Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy…Kimberly-Clark Corp. · 2009
- Descendant · 3 generations on · 2 of its ownK183057 PUMA-G SystemCoaptech, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK092049 Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009
- Descendant · 4 generations on · 1 of its ownK223916 PUMA-G SystemCoaptech, Inc. · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080253Kimberly-Clark Introducer KitsKimberly-Clark Corp. · 2008 · cites it directly10descendants
- K093312Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access…Kimberly-Clark Corp. · 2009 · 2 generations on5descendants
- K183057PUMA-G SystemCoaptech, LLC · 2019 · 3 generations on2descendants
- K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009 · 2 generations on2descendants
- K223916PUMA-G SystemCoaptech, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921370 | Mic Gastro-Enterostomy Tube Modification | Medical Innovations Corp. | 1994 | — |
| +1 | K080253 | Kimberly-Clark Introducer Kits | Kimberly-Clark Corp. | 2008 | — |
| +2 | K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal… | Kimberly-Clark Corp. | 2009 | — |
| +3 | K183057 | PUMA-G System | Coaptech, LLC | 2019 | — |
| +2 | K092049 | Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit | Sainath Intellectual Properties, LLC | 2009 | — |
| +4 | K223916 | PUMA-G System | Coaptech, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080253 | Kimberly-Clark Introducer Kits | 2008 | 10 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2024 | Class I | Z-1186-2024 | Nonconforming Material/Component | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. |
| Jan 16, 2024 | Class I | Z-1187-2024 | Nonconforming Material/Component | MIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080253 (Kimberly-Clark Corp., 2008) has gone furthest, with 10 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/K921370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921370: Mic Gastro-Enterostomy Tube Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921370
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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