510(k) · Cleared
ClearedCatco Nutritional Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catco Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Feb 24, 1995 after a 134-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.
- Decided
- Feb 24, 1995
- Review
- 134 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK945012 Catco Nutritional CatheterCatco Medical, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK072881 NEOMED Enteral FEEDING TUBENeomed, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
- Descendant · 2 generations on · 4 of its ownK082238 Neomed Polyurethane Feeding TubeNeomed, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK092628 Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010
- Descendant · 2 generations on · 2 of its ownK100526 Ameritus Entral (TM) Enteral Feeding TubeKentec Medical, Inc. · 2010 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072881NEOMED Enteral FEEDING TUBENeomed, Inc. · 2008 · cites it directly5descendants
- K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetNeochild, LLC · 2009 · cites it directly4descendants
- K082238Neomed Polyurethane Feeding TubeNeomed, Inc. · 2008 · 2 generations on4descendants
- K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010 · 2 generations on2descendants
- K100526Ameritus Entral (TM) Enteral Feeding TubeKentec Medical, Inc. · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945012 | Catco Nutritional Catheter | Catco Medical, Inc. | 1995 | — |
| +1 | K072881 | NEOMED Enteral FEEDING TUBE | Neomed, Inc. | 2008 | — |
| +1 | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | 2009 | — |
| +2 | K082238 | Neomed Polyurethane Feeding Tube | Neomed, Inc. | 2008 | 1 |
| +2 | K092628 | Enteral Feeding Tube and Accessories, Feeding Tube Extension Set | Alan Reid | 2010 | — |
| +2 | K100526 | Ameritus Entral (TM) Enteral Feeding Tube | Kentec Medical, Inc. | 2010 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (11)
See all 112 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K072881 (Neomed, Inc., 2008) has gone furthest, with 5 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/K945012 · printed Nov 5, 2026
Cite this page
510(k) Report. “K945012: Catco Nutritional Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K945012
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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