510(k) · Cleared
ClearedStandard Bougie, 38 Fr.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Standard Bariatrics · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 29, 2021 as substantially equivalent to K191885 (Standard Bariatrics, 2020) after a 137-day review. Its family tree reaches back 4 generations to 2001. 2 later devices descend from it.
- Decided
- Jun 29, 2021
- Review
- 137 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K002838 (2001). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 3 generations backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- 2 generations backK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- 1 generation backK191885 Standard BougieStandard Bariatrics · 2020
- This deviceK210437 Standard Bougie, 38 Fr.Standard Bariatrics · 2021
- Descendant · cites it directly · 0 of its ownK222085 Standard Tapered Bougie, 38 Fr.Standard Bariatrics, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK212728 Standard Bougie, 38 Fr. and Hand PumpStandard Bariatrics · 2021
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 |
|---|---|---|---|---|---|
| −4 | K002838 | Gastric Suction and Drainage Catheter | Bioenterics Corp. | 2001 | — |
| −3 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| −2 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| −1 | K191885 | Standard Bougie | Standard Bariatrics | 2020 | — |
| 0 (this device) | K210437 | Standard Bougie, 38 Fr. | Standard Bariatrics | 2021 | — |
| +1 | K222085 | Standard Tapered Bougie, 38 Fr. | Standard Bariatrics, Inc. | 2022 | — |
| +1 | K212728 | Standard Bougie, 38 Fr. and Hand Pump | Standard Bariatrics | 2021 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K191885 | Standard BougieSummary page 4…Tube, Gastrointestinal (And Accessories) (21 CFR 876.5980) Regulatory Class: II Product Code: KNT III. PREDICATE DEVICE Standard Bariatrics, Standard Bougie (SB18), K191885 IV. DEVICE DESCRIPTION The Standard Bougie SB38 is a single patient use, non-sterile device which consists of an 80 cm long… | 2020 |
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 20 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K222085 (Standard Bariatrics, Inc., 2022) has gone furthest, with 0 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. 2021, 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 BOUGIETM SB38 is indicated for use in conjunction with the Titan SGSTM 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/K210437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210437: Standard Bougie, 38 Fr..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210437
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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