# Gt Metabolic Solutions, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 5 (2024–2026): 4 510(k) clearances and 1 De Novo grant
- Product codes: SAH (5)
- 510(k) review time since 2016: median 135 days, against 135 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- GI Windows, Inc.: 1 (https://510kreport.com/company/gi-windows)

## Its most-cited devices
- K242086: MagDI System (MAG-01, DS-01) (2024), cited by 3
- DEN240013: MagDI System (2024), cited by 2
- K243359: MagDI System (MAG-02, DS-01) (2025), cited by 2
- K253102: GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (2026), cited by 1

## Recent decisions
- K261467: GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (Sep 16, 2026)
- K253102: GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) (Jun 4, 2026)
- K243359: MagDI System (MAG-02, DS-01) (Feb 28, 2025)
- K242086: MagDI System (MAG-01, DS-01) (Oct 24, 2024)
- DEN240013: MagDI System (Jul 2, 2024)

Source page: https://510kreport.com/company/gt-metabolic-solutions
