510(k) · Cleared
Recalled · 2008Dual Port Wizard Low Profile Replacement Gastrostomy Device; Dual Port Wizard Feeding/Decompression Tube, Model 00220W
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 19, 2001 after a 29-day review. The FDA summary names its predicate without a number. It has been recalled 45 times.
- Decided
- Oct 19, 2001
- Review
- 29 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 45
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
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? (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 |
|---|---|---|---|
| * | — | Wizard™ Low Profile Replacement Gastrostomy Device Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2008 | Not classified | Z-1112-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1099-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1097-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1107-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1114-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1113-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1111-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1096-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1103-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1110-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1115-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1117-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1100-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1108-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1102-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1098-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1105-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1101-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1116-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1106-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1104-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Dec 22, 2008 | Not classified | Z-1109-2009 | Process control | Out of specification replacement gastrostomy device was distributed. |
| Sep 23, 2008 | Not classified | Z-0418-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0419-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0420-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0423-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0424-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0431-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0432-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0416-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0421-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0422-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0425-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0428-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0429-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0427-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0430-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0435-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0437-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0438-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0417-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0426-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0433-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0434-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Sep 23, 2008 | Not classified | Z-0436-2009 | Component design/selection | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
The 5 latest of 45 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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 | — |
What is it indicated for?
The Dual Port Wizard™ replacement gastrostomy device is indicated for percutaneous placement of a low-profile gastrostomy feeding and decompression device into an established, appropriately sized stoma.
The Dual Port Wizard™ Feeding/Decompression Tube (REF 00220W) is the only device which should be used for feeding, gastric decompression or medication administration with the Dual Port Wizard replacement gastrostomy device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013144 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013144: Dual Port Wizard Low Profile Replacement Gastrostomy Device; Dual Port Wizard Feeding/Decompression Tube, Model 00220W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013144
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026