510(k) · Cleared
ClearedEndoflip Gastric Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crospon, Ltd. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 22, 2011 as substantially equivalent to K002838 (Bioenterics Corp., 2001) after a 148-day review. Its family tree reaches back 1 generation to 2001. 16 later devices descend from it.
- Decided
- Jul 22, 2011
- Review
- 148 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002838 (2001). 16 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- This deviceK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- Descendant · cites it directly · 15 of its ownK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- Descendant · 2 generations on · 3 of its ownK191885 Standard BougieStandard Bariatrics · 2020
- Descendant · 3 generations on · 2 of its ownK210437 Standard Bougie, 38 Fr.Standard Bariatrics · 2021
- Descendant · 2 generations on · 1 of its ownK234033 ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK234145 ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K130483Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013 · cites it directly15descendants
- K191885Standard BougieStandard Bariatrics · 2020 · 2 generations on3descendants
- K210437Standard Bougie, 38 Fr.Standard Bariatrics · 2021 · 3 generations on2descendants
- K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC · 2024 · 2 generations on1descendant
- K234145ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| 0 (this device) | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| +1 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| +2 | K191885 | Standard Bougie | Standard Bariatrics | 2020 | — |
| +3 | K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021 | — |
| +2 | K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | 2024 | — |
| +2 | K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
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 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? (1)
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 |
|---|---|---|---|
| * | K002838 | Gastric Suction and Drainage CatheterSummary page 1…sification / CFll: KNT -CFR 876.1500 Device: EndoFLIP® Gastric Tube EF-900 Predicate Devices: K002838 - BioEnterics® Gastric Balloon Suction Catheter Device Description: The EndoFLIP® Gastr… | 2001 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130483 | Boehringer Gastric Sizing Tube | 2013 | 15 |
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?
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and EF-325 catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110529: Endoflip Gastric Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110529
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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