510(k) · Cleared
ClearedRealize Gastric Calibration Tube, Models GCT180, GCT360
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obtech Medical Sarl · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 24, 2007 after a 117-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Oct 24, 2007
- Review
- 117 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK071764 Realize Gastric Calibration Tube, Models GCT180, GCT360Obtech Medical Sarl · 2007
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K071764 | Realize Gastric Calibration Tube, Models GCT180, GCT360 | Obtech Medical Sarl | 2007 | — |
| +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? (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 |
|---|---|---|---|
| * | — | COOK® Gastric Sizing Balloon Catheter Named without a submission number | |
| * | — | BioEnterics® Gastric Balloon Suction Catheter Named without a submission number |
What descends from it? (16)
See all 163 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, K130483 (Boehringer Laboratories, LLC, 2013) has gone furthest, with 15 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. 2007, 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 gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071764 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071764: Realize Gastric Calibration Tube, Models GCT180, GCT360.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071764
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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