510(k) · Cleared
ClearedMagDI System (MAG-02, DS-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gt Metabolic Solutions, Inc. · SAH Magnetic Compression Anastomosis System
Cleared on Feb 28, 2025 as substantially equivalent to K242086 (Gt Metabolic Solutions, Inc., 2024) after a 122-day review. Its family tree reaches back 2 generations to 2024. 2 later devices descend from it.
- Decided
- Feb 28, 2025
- Review
- 122 days
- Class
- Class II
- Product code
- SAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN240013 (2024). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN240013 MagDI SystemGt Metabolic Solutions, Inc. · 2024
- 1 generation backK242086 MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. · 2024
- This deviceK243359 MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK253102 GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK261467 GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System…Gt Metabolic Solutions, Inc. · 2026
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 | DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | 2024 | — |
| −1 | K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | 2024 | — |
| 0 (this device) | K243359 | MagDI System (MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2025 | — |
| +1 | K253102 | GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) | Gt Metabolic Solutions, Inc. | 2026 | — |
| +1 | K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05… | Gt Metabolic Solutions, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 SAH? 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 SAH device
- #1 K242086 MagDI System (MAG-01, DS-01)score 17.2 · 1 generation · 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 |
|---|---|---|---|
| * | K242086 | MagDI System (MAG-01, DS-01)Summary page 5…etabolic MagDI™ System Device Common Name: Magnet System Model Numbers: MAG-01 DS-01 Submission Number: K242086 Product Code Name: Magnetic compression anastomosis system Product Code: SAH Regulation Number:… | 2024 |
| † | DEN240013 | MagDI System | 2024 |
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 1 year and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253102 (Gt Metabolic Solutions, Inc., 2026) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K242086.
How does its category compare?
All SAH devicesSAH Magnetic Compression Anastomosis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SAH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SAH
140in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · SAH
No recall names SAH since 2007.
Adverse event reports per year · SAH
No MAUDE report names SAH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 4 | 140 | 0 | 0 |
| 2026 | 3 | 135 | 0 | — |
What is it indicated for?
The GT Metabolic MagDI™ System is intended for use in the creation of side-to-side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.
The GT Metabolic MagDI System is intended for use in adult patients > 21 years.
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/K243359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243359: MagDI System (MAG-02, DS-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243359
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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