# GI Windows, Inc.

- Location (FDA's records): Westwood, MA
- FDA decisions: 4 (2025–2026): 4 510(k) clearances
- Product codes: SAH (4)
- 510(k) review time since 2016: median 138 days, against 140 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gt Metabolic Solutions, Inc.: 1 (https://510kreport.com/company/gt-metabolic-solutions)
- Niti Medical Technologies, Ltd.: 1 (https://510kreport.com/company/niti-medical-technologies)

## Its most-cited devices
- K243213: Self-Forming Magnet (FLEX SFM) (2025), cited by 1
- K250541: Self-Forming Magnet (Flexagon Plus OTOLoc) (2025), cited by 1
- K243482: Self-Forming Magnet (Flexagon) (2025), cited by 1

## Recent decisions
- K253550: Self-Forming Magnet (Flexagon Plus OTOLoc) (Jan 9, 2026)
- K250541: Self-Forming Magnet (Flexagon Plus OTOLoc) (Aug 1, 2025)
- K243482: Self-Forming Magnet (Flexagon) (Jun 11, 2025)
- K243213: Self-Forming Magnet (FLEX SFM) (Jan 29, 2025)

Source page: https://510kreport.com/company/gi-windows