# K033562: Fastrac Gastric Access Port Kit

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 12, 2003 after 30 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972025 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972025: Radius Pull Percutaneous Endoscopic Gastrostomy Kit, Radius Intl., Inc. (1998) Summary page 1.
- K972102: Radius Push Over the Guide Wire Percutaneous Endoscopic Gastrostomy Kit, Radius Intl., Inc. (1998) Summary page 1.

## Recalls of this device
- Dec 4, 2008 · Not classified · Z-2187-2009: 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
- Dec 4, 2008 · Not classified · Z-2179-2009: 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 
- Dec 4, 2008 · Not classified · Z-2186-2009: 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 
- Dec 4, 2008 · Not classified · Z-2200-2009: 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 
- Dec 4, 2008 · Not classified · Z-2203-2009: 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 
- Dec 4, 2008 · Not classified · Z-2183-2009: 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 
- Dec 4, 2008 · Not classified · Z-2185-2009: 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 
- Dec 4, 2008 · Not classified · Z-2184-2009: 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 
- Dec 4, 2008 · Not classified · Z-2205-2009: 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 
- Dec 4, 2008 · Not classified · Z-2191-2009: 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 
- Dec 4, 2008 · Not classified · Z-2193-2009: 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 
- Dec 4, 2008 · Not classified · Z-2194-2009: 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 
- Dec 4, 2008 · Not classified · Z-2204-2009: 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 
- Dec 4, 2008 · Not classified · Z-2197-2009: 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 
- Dec 4, 2008 · Not classified · Z-2206-2009: 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 
- Dec 4, 2008 · Not classified · Z-2192-2009: 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 
- Dec 4, 2008 · Not classified · Z-2189-2009: 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 
- Dec 4, 2008 · Not classified · Z-2181-2009: 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 
- Dec 4, 2008 · Not classified · Z-2198-2009: 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 
- Dec 4, 2008 · Not classified · Z-2195-2009: 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 
- Dec 4, 2008 · Not classified · Z-2180-2009: 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 
- Dec 4, 2008 · Not classified · Z-2196-2009: 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 
- Dec 4, 2008 · Not classified · Z-2188-2009: 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
- Dec 4, 2008 · Not classified · Z-2201-2009: 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 
- Dec 4, 2008 · Not classified · Z-2207-2009: 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 
- Dec 4, 2008 · Not classified · Z-2199-2009: 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 
- Dec 4, 2008 · Not classified · Z-2190-2009: 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 
- Dec 4, 2008 · Not classified · Z-2182-2009: 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 
- Dec 4, 2008 · Not classified · Z-2202-2009: 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 

## Indications for use
The FastracTM Gastric Access Port System is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.

Source page: https://510kreport.com/device/K033562
Methodology: https://510kreport.com/methodology