510(k) · Cleared
ClearedWilson-Cook Russell Gastrostomy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Sep 5, 1991 after a 119-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Sep 5, 1991
- Review
- 119 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK912047 Wilson-Cook Russell Gastrostomy KitWilson-Cook Medical, Inc. · 1991
- Descendant · cites it directly · 4 of its ownK021034 Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK043258 Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004
- Descendant · 3 generations on · 1 of its ownK070449 Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007
- Descendant · 3 generations on · 0 of its ownK211072 Safety Trocar CannulaBoston Scientific Corporation · 2021
- Descendant · 3 generations on · 0 of its ownK180725 Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K021034Modified TFX Medical Safety Needle with IntroducerTfx Medical, Inc. · 2002 · cites it directly4descendants
- K043258Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02Teleflex Medical · 2004 · 2 generations on3descendants
- K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc. · 2007 · 3 generations on1descendant
- K211072Safety Trocar CannulaBoston Scientific Corporation · 2021 · 3 generations on0descendants
- K180725Aspire Introducer NeedleAspire Bariatrics, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912047 | Wilson-Cook Russell Gastrostomy Kit | Wilson-Cook Medical, Inc. | 1991 | — |
| +1 | K021034 | Modified TFX Medical Safety Needle with Introducer | Tfx Medical, Inc. | 2002 | — |
| +2 | K043258 | Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02 | Teleflex Medical | 2004 | — |
| +3 | K070449 | Lumiloc (TM) Safety Introducer Needle | Specialized Health Products International, Inc. | 2007 | — |
| +3 | K211072 | Safety Trocar Cannula | Boston Scientific Corporation | 2021 | — |
| +3 | K180725 | Aspire Introducer Needle | Aspire Bariatrics, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (6)
2 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, K021034 (Tfx Medical, Inc., 2002) has gone furthest, with 4 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/K912047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912047: Wilson-Cook Russell Gastrostomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912047
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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