510(k) · Cleared
ClearedXNY Disposable Gastric Calibration Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 10, 2025 as substantially equivalent to K221898 (Reshape Lifesciences, 2022) after a 58-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Apr 10, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002838 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 2 generations backK220455 Lap-Band System Calibration TubeReshape Lifesciences · 2022
- 1 generation backK221898 Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences · 2022
- This deviceK250389 XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
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 | K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | 2022 | — |
| −1 | K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022 | — |
| 0 (this device) | K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025 | — |
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 |
|---|---|---|---|
| * | K221898 | Gastrointestinal Boundary Identifier (GIBI HD)Summary page 5…876.5980 Gastrointestinal tube and accessories Classification Class II Predicate Device Gastrointestinal Boundary Identifier (GIBI HD™), K221898 2. Device Description The XNY Disposable Gastric Calibration Tubes are indicated for use in gastric and bariatric su… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K221898.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
XNY Disposable Gastric Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250389: XNY Disposable Gastric Calibration Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250389
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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