510(k) · Cleared
ClearedDecompression Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technologies · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 28, 1992 after a 67-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Apr 28, 1992
- Review
- 67 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK920894 Decompression TubesApplied Medical Technologies · 1992
- Descendant · cites it directly · 1 of its ownK161003 EndoVive One Step Button Low Profile Initial Placement PEG Kit with…Boston Scientific Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK191844 Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK980145 Amt Decompression TubesApplied Medical Technology, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K161003EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector…Boston Scientific Corporation · 2016 · cites it directly1descendant
- K191844Fidmi Low Profile Enteral Feeding DeviceFidmi Medical, Ltd. · 2019 · 2 generations on0descendants
- K980145Amt Decompression TubesApplied Medical Technology, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920894 | Decompression Tubes | Applied Medical Technologies | 1992 | — |
| +1 | K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit… | Boston Scientific Corporation | 2016 | 1 |
| +2 | K191844 | Fidmi Low Profile Enteral Feeding Device | Fidmi Medical, Ltd. | 2019 | — |
| +1 | K980145 | Amt Decompression Tubes | Applied Medical Technology, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 12.7 · 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K161003 (Boston Scientific Corporation, 2016) has gone furthest, with 1 descendant of its own.
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
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 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 | — |
https://510kreport.com/device/K920894 · printed Nov 5, 2026
Cite this page
510(k) Report. “K920894: 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/K920894
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026