510(k) · Cleared
Recalled · 2008Fastrac Gastric Access Port Kit
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 Dec 12, 2003 as substantially equivalent to K972025 (Radius Intl., Inc., 1998) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1998. It has been recalled 29 times.
- Decided
- Dec 12, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 29
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972025 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972025 Radius Pull Percutaneous Endoscopic Gastrostomy KitRadius Intl., Inc. · 1998 · Recalled
- This deviceK033562 Fastrac Gastric Access Port KitC.R. Bard, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972025 | Radius Pull Percutaneous Endoscopic Gastrostomy Kit | Radius Intl., Inc. | 1998 | 29 |
| 0 (this device) | K033562 | Fastrac Gastric Access Port Kit | C.R. Bard, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 12.8 · 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? (2)
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 |
|---|---|---|---|
| * | K972025 | Radius Pull Percutaneous Endoscopic Gastrostomy KitSummary page 1…FastracTM Gastric Access Port Guidewire Safety System C. Predicate Devices: FastracTM Gastric Access Port Pull PEG System (K972025), Fastrac M Gastric Access Port Guidewire PEG System (K972102) D. Device Description:… | 1998 |
| * | K972102 | Radius Push Over the Guide Wire Percutaneous Endoscopic Gastrostomy KitSummary page 1…C. Predicate Devices: FastracTM Gastric Access Port Pull PEG System (K972025), Fastrac M Gastric Access Port Guidewire PEG System (K972102) D. Device Description: The FASTRACTM Gastric Access Port device is a silicone balloon-type fee… | 1998 |
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 4, 2008 | Not classified | Z-2187-2009 | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating… |
| Dec 4, 2008 | Not classified | Z-2179-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2186-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2200-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2203-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2183-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2185-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2184-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2205-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2191-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2193-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2194-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2204-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2197-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2206-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2192-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2189-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2181-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2198-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2195-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2180-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2196-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2188-2009 | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating… |
| Dec 4, 2008 | Not classified | Z-2201-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2207-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2199-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2190-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2182-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2202-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
The 5 latest of 29 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
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
2007high 16 (2014) · low 4 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
2007high 259 (2014) · low 99 (2016)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
2007high 82 (2008) · low 0 (2013)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
2007high 1,901 (2018) · low 300 (2007)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 FastracTM Gastric Access Port System is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033562 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033562: Fastrac Gastric Access Port Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033562
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026