510(k) · Cleared
ClearedGastrointestinal Boundary Identifier (GIBI HD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reshape Lifesciences · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 28, 2022 as substantially equivalent to K220455 (Reshape Lifesciences, 2022) after a 28-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Jul 28, 2022
- Review
- 28 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002838 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 1 generation backK220455 Lap-Band System Calibration TubeReshape Lifesciences · 2022
- This deviceK221898 Gastrointestinal Boundary Identifier (GIBI HD)Reshape Lifesciences · 2022
- Descendant · cites it directly · 0 of its ownK250389 XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
- Descendant · cites it directly · 0 of its ownK230131 ReShape Calibration TubesReshape Lifesciences · 2023
Most influential descendants
Showing 2 of 2 · See allView 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 | K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | 2022 | — |
| 0 (this device) | K221898 | Gastrointestinal Boundary Identifier (GIBI HD) | Reshape Lifesciences | 2022 | — |
| +1 | K250389 | XNY Disposable Gastric Calibration Tube | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025 | — |
| +1 | K230131 | ReShape Calibration Tubes | Reshape Lifesciences | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K220455 | Lap-Band System Calibration TubeSummary page 4…d accessories (21 CFR 876.5980) Regulatory Class Class II Product Code KNT Predicate Device Lap-Band® System Calibration Tube, K220455 Reference Device ViSiGi 3D®, K130483 II. DEVICE DESCRIPTION The Gastrointestinal Boundary Identifier, or GI… | 2022 |
| † | K130483 | Boehringer Gastric Sizing Tube | 2013 |
What descends from it? (2)
2 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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 20.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K250389 (Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K220455.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 GIBI HDTM is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221898 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221898: Gastrointestinal Boundary Identifier (GIBI HD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221898
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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