510(k) · Cleared
ClearedViSiGi 3D Gastric Sizing Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Laboratories · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jan 26, 2024 as substantially equivalent to K130483 (Boehringer Laboratories, LLC, 2013) after a 28-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Jan 26, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002838 (2001). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 2 generations backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- 1 generation backK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- This deviceK234145 ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories · 2024
- Descendant · cites it directly · 0 of its ownK261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| −2 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| −1 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| 0 (this device) | K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024 | — |
| +1 | K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | Boehringer Laboratories, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K130483 | Boehringer Gastric Sizing TubeSummary page 5…s) Regulation: 21 CFR 876.5980 Product Code: KNT Class: II 510(k) Clearance: K130483 13.4 Reference Device Trade Name: Endolumik Fluorescence Guided Gastric Calibration Tube Common Name:… | 2013 |
| † | K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261890 | 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D® | 2026 | 0 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 10.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K261890 (Boehringer Laboratories, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K130483.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
ViSiGi 3D is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, and to serve as a sizing guide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K234145: ViSiGi 3D Gastric Sizing Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234145
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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