510(k) · Cleared
ClearedMidsleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Innovation Development · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 23, 2015 as substantially equivalent to K071764 (Obtech Medical Sarl, 2007) and 1 other predicate after a 286-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Jun 23, 2015
- Review
- 286 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002838 (2001). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
- 2 generations backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
- 1 generation backK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
- This deviceK142548 MidsleeveMedical Innovation Development · 2015
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 | K110529 | Endoflip Gastric Tube | Crospon, Ltd. | 2011 | — |
| −1 | K130483 | Boehringer Gastric Sizing Tube | Boehringer Laboratories, LLC | 2013 | — |
| 0 (this device) | K142548 | Midsleeve | Medical Innovation Development | 2015 | — |
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? (2)
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 |
|---|---|---|---|
| * | K071764 | Realize Gastric Calibration Tube, Models GCT180, GCT360Summary page 4…[email protected] 4 MIDSLEE\)ETM, Calibration Tube for Sleeve Gastrectomy Gastrointestinal tube and accessories Class I KNT 21 CFR 876.5980 REALIZE™ Calibration Tube K071764 Boehringer Laboratories Gastric Sizing Tube K130483 K142548/003 - Section 6 — Page 1/ 6 K 142548 Page 2 of 6 -~… | 2007 |
| * | K130483 | Boehringer Gastric Sizing TubeSummary page 4…or Sleeve Gastrectomy Gastrointestinal tube and accessories Class I KNT 21 CFR 876.5980 REALIZE™ Calibration Tube K071764 Boehringer Laboratories Gastric Sizing Tube K130483 K142548/003 - Section 6 — Page 1/ 6 K 142548 Page 2 of 6 -~ Medical Innovatlpn Develpppement T:+334 78 17 48 04… | 2013 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K071764.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
MIDSLEEVE, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as
Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.
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/K142548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142548: Midsleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142548
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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