# Amnisure International, LLC

- Location (FDA's records): Cambridge, MA
- FDA decisions: 1 (2009–2009): 1 510(k) clearance
- Product codes: NQM (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Clinical Innovations, Inc.: 1 (https://510kreport.com/company/clinical-innovations)

## Its most-cited devices
- K081767: Amnisure Fetal Membranes Rupture Test, Model FMRT-1 (2009), cited by 1

## Recent decisions
- K081767: Amnisure Fetal Membranes Rupture Test, Model FMRT-1 (Jan 9, 2009)

Source page: https://510kreport.com/company/amnisure-international