# K013144: Dual Port Wizard Low Profile Replacement Gastrostomy Device; Dual Port Wizard Feeding/Decompression Tube, Model 00220W

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 19, 2001 after 29 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 45 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wizard™ Low Profile Replacement Gastrostomy Device: named in the summary without a submission number

## Recalls of this device
- Dec 22, 2008 · Not classified · Z-1112-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1099-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1097-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1107-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1114-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1113-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1111-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1096-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1103-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1110-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1115-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1117-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1100-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1108-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1102-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1098-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1105-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1101-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1116-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1106-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1104-2009: Out of specification replacement gastrostomy device was distributed.
- Dec 22, 2008 · Not classified · Z-1109-2009: Out of specification replacement gastrostomy device was distributed.
- Sep 23, 2008 · Not classified · Z-0418-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0419-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0420-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0423-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0424-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0431-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0432-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0416-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0421-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0422-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0425-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0428-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0429-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0427-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0430-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0435-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0437-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0438-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0417-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0426-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0433-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0434-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- Sep 23, 2008 · Not classified · Z-0436-2009: Gastrostomy device anti-reflux valve may allow leakage from the stomach.

## Indications for use
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.

Source page: https://510kreport.com/device/K013144
Methodology: https://510kreport.com/methodology