510(k) · Cleared
ClearedBoehringer Gastric Sizing Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Laboratories, LLC · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Mar 28, 2013 as substantially equivalent to K071764 (Obtech Medical Sarl, 2007) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 2001. 15 later devices descend from it.
- Decided
- Mar 28, 2013
- Review
- 31 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002838 (2001). 3 ancestors in all. 15 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 1 generation backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- This deviceK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- Descendant · cites it directly · 3 of its ownK191885 Standard BougieStandard Bariatrics · 2020
- Descendant · 2 generations on · 2 of its ownK210437 Standard Bougie, 38 Fr.Standard Bariatrics · 2021
- Descendant · cites it directly · 1 of its ownK234033 ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC · 2024
- Descendant · cites it directly · 1 of its ownK234145 ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories · 2024
- Descendant · cites it directly · 1 of its ownK222880 Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc. · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K191885Standard BougieStandard Bariatrics · 2020 · cites it directly3descendants
- K210437Standard Bougie, 38 Fr.Standard Bariatrics · 2021 · 2 generations on2descendants
- K234033ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)Boehringer Laboratories, LLC · 2024 · cites it directly1descendant
- K234145ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories · 2024 · cites it directly1descendant
- K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)Endolumik, Inc. · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| −1 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| 0 (this device) | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| +1 | K191885 | Standard Bougie | Standard Bariatrics | 2020 | — |
| +2 | K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021 | — |
| +1 | K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | Boehringer Laboratories, LLC | 2024 | — |
| +1 | K234145 | ViSiGi 3D Gastric Sizing Tube | Boehringer Laboratories | 2024 | — |
| +1 | K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | Endolumik, Inc. | 2023 | — |
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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K071764 | Realize Gastric Calibration Tube, Models GCT180, GCT360Summary page 1…ion: 876.5980 Classification Panel: General & Plastic Surgery PREDICATE DEVICES: REALIZE TM Gastric Calibration Tube K071 764 EndoFLIP® Gastric Tube EF-900 K1 10529 DEVICE DESCRIPTION: The Boehrin… | 2007 |
| * | K110529 | Endoflip Gastric TubeSummary page 1…ATE DEVICES: REALIZE TM Gastric Calibration Tube K071 764 EndoFLIP® Gastric Tube EF-900 K1 10529 DEVICE DESCRIPTION: The Boehringer Laboratories Gastric Sizing Tube is a single patient use, non-sterile device wh… | 2011 |
What descends from it? (15)
See all 158 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191885 | Standard Bougie | 2020 | 3 |
| K234033 | ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) | 2024 | 1 |
| K234145 | ViSiGi 3D Gastric Sizing Tube | 2024 | 1 |
| K222880 | Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) | 2023 | 1 |
| K220218 | Siren SGT | 2022 | 1 |
| K143088 | GastriSail Gastric Positioning System | 2015 | 1 |
| K212407 | Gastric Lightguide (GLG) | 2022 | 0 |
| K142548 | Midsleeve | 2015 | 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 12 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K191885 (Standard Bariatrics, 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K071764.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Boehringer Laboratories Gastric Sizing Tube is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130483: Boehringer Gastric Sizing Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130483
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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