510(k) · Cleared
ClearedGT Metabolic MagDI System (MAG-01, 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 Jun 4, 2026 as substantially equivalent to K242086 (Gt Metabolic Solutions, Inc., 2024) and 1 other predicate after a 253-day review. Its family tree reaches back 3 generations to 2024. 1 later device descends from it.
- Decided
- Jun 4, 2026
- Review
- 253 days
- Class
- Class II
- Product code
- SAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN240013 (2024). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN240013 MagDI SystemGt Metabolic Solutions, Inc. · 2024
- 2 generations backK242086 MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. · 2024
- 1 generation backK243359 MagDI System (MAG-02, DS-01)Gt Metabolic Solutions, Inc. · 2025
- This deviceK253102 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −3 | DEN240013 | MagDI System | Gt Metabolic Solutions, Inc. | 2024 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | 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 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? (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 |
|---|---|---|---|
| * | K242086 | MagDI System (MAG-01, DS-01)Summary page 6…MagDI™ System Device Common Name: Magnet System Model Numbers: MAG-01, MAG-02 DS-01 Submission Number(s): K242086, K243359 Product Code Name: Magnetic compression anastomosis system Product Code: SAH Regulation Numbe… | 2024 |
| * | K243359 | MagDI System (MAG-02, DS-01)Summary page 6…ystem Device Common Name: Magnet System Model Numbers: MAG-01, MAG-02 DS-01 Submission Number(s): K242086, K243359 Product Code Name: Magnetic compression anastomosis system Product Code: SAH Regulation Number:… | 2025 |
| † | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261467 | GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) | 2026 | 0 |
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 2 years and passes through 1 company; a new generation was cleared every 4 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K261467 (Gt Metabolic Solutions, Inc., 2026) has gone furthest, with 0 descendants 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. 2026, 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 (MAG-01, MAG-02, DS-01) is intended for use in the creation of side-to-side anastomoses throughout the small bowel 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 MagDITM System is intended for use in adult patients >21 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253102 · printed Nov 3, 2026
Cite this page
510(k) Report. “K253102: GT Metabolic MagDI System (MAG-01, MAG-02, DS-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K253102
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026