# K980145: Amt Decompression Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Apr 10, 1998 after 85 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920894 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920894: Decompression Tubes, Applied Medical Technologies (1992) Summary page 1.
- (no number) Microvasive/Boston Scientific Corp. - One Step Button and Replacement Button Decompression Tubes: named in the summary without a submission number
- (no number) C.R. Bard - One Step Button Decompression Tubes: named in the summary without a submission number

## Indications for use
The AMT Decompression Tubes are used to allow decompression of gasses from a patient’s stomach when the patient is using an AMT Button, AMT One Step Button, BARD Button, Surgitek One Step Button, Microvasive One Step Button, AMT Replacement Buttons, or other similar button feeding device that has an anti-reflux valve incorporated. By inserting the proper size decompression tube into the button feeding port, the decompression tube will open the anti-reflux valve, allowing patient stomach decompression without damaging the anti-reflux valve. Opening the anti-reflux valve relieves gaseous pressure in the patient’s stomach by allowing the gas to escape through the decompression tube providing comfort to the patient. Other uses are not recommended.

Source page: https://510kreport.com/device/K980145
Methodology: https://510kreport.com/methodology