510(k) · Cleared
ClearedGastric Suction and Drainage Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioenterics Corp. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 9, 2001 after a 300-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 24 later devices descend from it.
- Decided
- Jul 9, 2001
- Review
- 300 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 3 citing it directly.
- This deviceK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- Descendant · cites it directly · 16 of its ownK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- Descendant · 2 generations on · 15 of its ownK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- Descendant · cites it directly · 4 of its ownK220455 Lap-Band System Calibration TubeReshape Lifesciences · 2022
- Descendant · 3 generations on · 3 of its ownK191885 Standard BougieStandard Bariatrics · 2020
- Descendant · 2 generations on · 2 of its ownK221898 Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences · 2022
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K110529Endoflip Gastric TubeCrospon, Ltd. · 2011 · cites it directly16descendants
- K130483Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013 · 2 generations on15descendants
- K220455Lap-Band System Calibration TubeReshape Lifesciences · 2022 · cites it directly4descendants
- K191885Standard BougieStandard Bariatrics · 2020 · 3 generations on3descendants
- K221898Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences · 2022 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| +1 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| +2 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| +1 | K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | 2022 | — |
| +3 | K191885 | Standard Bougie | Standard Bariatrics | 2020 | — |
| +2 | K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (24)
See all 243 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, K110529 (Crospon, Ltd., 2011) has gone furthest, with 16 descendants 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/K002838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002838: Gastric Suction and Drainage Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002838
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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