510(k) · Cleared
ClearedMagDI System (MAG-01, 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 Oct 24, 2024 as substantially equivalent to DEN240013 (Gt Metabolic Solutions, Inc., 2024) after a 99-day review. Its family tree reaches back 1 generation to 2024. 3 later devices descend from it.
- Decided
- Oct 24, 2024
- Review
- 99 days
- Class
- Class II
- Product code
- SAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240013 (2024). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN240013 MagDI SystemGt Metabolic Solutions, Inc. · 2024
- This deviceK242086 MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK243359 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 3 of 3 · See all- K243359MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2025 · cites it directly2descendants
- K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2026 · cites it directly1descendant
- K261467GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01)Gt Metabolic Solutions, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | 2024 | — |
| 0 (this device) | K242086 | MagDI System (MAG-01, DS-01) | Gt Metabolic Solutions, Inc. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 2025 | 1 | 0 |
| 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 K250541 Self-Forming Magnet (Flexagon Plus OTOLoc)score 15.8 · 11 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 |
|---|---|---|---|
| * | DEN240013 | MagDI SystemSummary page 5…lic MagDI™ System Device Common Name: Magnet System Model Numbers: MAG-00(US) DS- 00(US) Submission Number: DEN240013 Product Code Name: Magnetic compression anastomosis system Product Code: SAH Regulation Number:… | 2024 |
| † | K881484 | Biofragmentable Bowel Anastomosis Ring | 1988 |
| † | K913411 | Davis & Geck Valtrac (R) Biofrag Anastomosis Ring | 1991 |
| † | K931056 | Davis+Geck Valtrac Biofrag Anastomosis Ring | 1993 |
What descends from it? (3)
3 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?
How does its category compare?
All SAH devicesSAH Magnetic Compression Anastomosis System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 MagDIl 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 > 21years.
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/K242086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242086: MagDI System (MAG-01, DS-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242086
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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