510(k) · Cleared
ClearedStandard Tapered Bougie, 38 Fr.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Bariatrics, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 31, 2022 as substantially equivalent to K210437 (Standard Bariatrics, 2021) after a 108-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Oct 31, 2022
- Review
- 108 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002838 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 4 generations backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- 3 generations backK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- 2 generations backK191885 Standard BougieStandard Bariatrics · 2020
- 1 generation backK210437 Standard Bougie, 38 Fr.Standard Bariatrics · 2021
- This deviceK222085 Standard Tapered Bougie, 38 Fr.Standard Bariatrics, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| −4 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| −3 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| −2 | K191885 | Standard Bougie | Standard Bariatrics | 2020 | — |
| −1 | K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021 | — |
| 0 (this device) | K222085 | Standard Tapered Bougie, 38 Fr. | Standard Bariatrics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K210437 | Standard Bougie, 38 Fr.Summary page 4…ation Number: 21 CFR 876.5980 Regulatory Class: II Product Code: KNT III. PREDICATE DEVICE Name of Device: Standard Bariatrics, Standard Bougie, SB38 510(k) Number: K210437 Common or Usual Name: Gastrointestinal tube and accessories Classification Name: Gastrointestinal tube and accessories Regulation… | 2021 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K210437.
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 Standard Tapered Bougie, 38Fr (STB38) is indicated for use in conjunction with the Titan SGS® stapler in vertical sleeve gastrectomy pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222085: Standard Tapered Bougie, 38 Fr..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222085
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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