510(k) · Cleared
ClearedAmt Decompression Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technology, Inc. · KGC Tube, Gastro-Enterostomy
Cleared on Apr 10, 1998 as substantially equivalent to K920894 (Applied Medical Technologies, 1992) after an 85-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Apr 10, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920894 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920894 Decompression TubesApplied Medical Technologies · 1992
- This deviceK980145 Amt Decompression TubesApplied Medical Technology, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920894 | Decompression Tubes | Applied Medical Technologies | 1992 | — |
| 0 (this device) | K980145 | Amt Decompression Tubes | Applied Medical Technology, Inc. | 1998 | — |
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 KGC? 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 KGC device
- #1 K242211 PUMA-G Pediatric Systemscore 10.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K920894 | Decompression TubesSummary page 1…Gastrointestinal Tube Accessories (78KGC) Substantial Equivalency is claimed against the following devices: 1. Applied Medical Technology, Inc. - Decompression Tubes - K920894 2. Microvasive/Boston Scientific Corp. - One Step Button and Replacement Button Decompression Tubes 3. CR.Bard - One Step Butt… | 1992 |
| * | — | Microvasive/Boston Scientific Corp. - One Step Button and Replacement Button… Named without a submission number | |
| * | — | C.R. Bard - One Step Button Decompression Tubes 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K920894.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGC
159in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGC
106in 2025
MAUDE reports naming product code KGC, 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 | 0 | — | 0 | 12 |
| 2008 | 2 | — | 0 | 30 |
| 2009 | 1 | — | 5 | 47 |
| 2010 | 0 | — | 6 | 67 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 41 |
| 2015 | 0 | — | 1 | 72 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 1 | — | 0 | 102 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 3 | 159 | 0 | 90 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 0 | — | 0 | 73 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 1 | — | 0 | 106 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (112 words)
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.
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/K980145 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980145: Amt Decompression Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980145
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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