510(k) · Cleared
ClearedStandard Bougie, 38 Fr. and Hand Pump
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 Sep 23, 2021 as substantially equivalent to K210437 (Standard Bariatrics, 2021) after a 27-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Sep 23, 2021
- Review
- 27 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 deviceK212728 Standard Bougie, 38 Fr. and Hand PumpStandard Bariatrics · 2021
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) | 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 |
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…iption: Gastrointestinal tube and accessories Regulatory Class: Class II Regulation: 21 CFR 876.5980 Product Code: KNT III. Predicate Device: Standard Bougie (SB38), K210437, 21CFR 876.5980, Class II, Product Code KNT Standard Bariatrics IV. Device Description The Standard Bougie (SB38) is a singl… | 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 20 years and passes through 4 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. 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 BOUGIE SB38 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212728: Standard Bougie, 38 Fr. and Hand Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212728
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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