510(k) · Cleared
ClearedSelf-Forming Magnet (FLEX SFM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GI Windows, Inc. · SAH Magnetic Compression Anastomosis System
Cleared on Jan 29, 2025 as substantially equivalent to DEN240013 (Gt Metabolic Solutions, Inc., 2024) after a 118-day review. Its family tree reaches back 1 generation to 2024. 3 later devices descend from it.
- Decided
- Jan 29, 2025
- Review
- 118 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, 1 citing it directly.
- Root · 1 generation backDEN240013 MagDI SystemGt Metabolic Solutions, Inc. · 2024
- This deviceK243213 Self-Forming Magnet (FLEX SFM)GI Windows, Inc. · 2025
- Descendant · cites it directly · 2 of its ownK243482 Self-Forming Magnet (Flexagon)GI Windows, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK250541 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK253550 Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView 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) | K243213 | Self-Forming Magnet (FLEX SFM) | GI Windows, Inc. | 2025 | — |
| +1 | K243482 | Self-Forming Magnet (Flexagon) | GI Windows, Inc. | 2025 | — |
| +2 | K250541 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2025 | — |
| +3 | K253550 | Self-Forming Magnet (Flexagon Plus OTOLoc) | GI Windows, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 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? (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 6…gnet Classification Name: Magnetic Compression Anastomosis System Regulation Number: 878.4816 Product Codes: SAH Legally Marketed Predicate: Mag DI (DEN240013) - Product Code: SAH Device Description Summary The FLEX SFM device is a magnetic compression anastomosis system, which is a su… | 2024 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243482 | Self-Forming Magnet (Flexagon) | 2025 | 2 |
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. 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 GI Windows FLEX SFM 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 GI Windows FLEX SFM is intended for use in adult patients > 21 years.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243213: Self-Forming Magnet (FLEX SFM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243213
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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