# Zoe Medical, Inc.

- Location (FDA's records): Topsfield, MA
- FDA decisions: 5 (2001–2021): 5 510(k) clearances
- Product codes: DXN (2), MWI (2), DRT (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 6 (1 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spacelabs Healthcare Medical Equipment (Suzhou) CO: 2 (https://510kreport.com/company/spacelabs-healthcare-medical-equipment-suzhou)
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)
- Healthtech Services Corp.: 1 (https://510kreport.com/company/healthtech-services)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)

## Firms that cite its devices most
- Brentwood Medical Technology Corp.: 1 (https://510kreport.com/company/brentwood-medical-technology)
- Spacelabs Healthcare Medical Equipment (Suzhou) CO: 1 (https://510kreport.com/company/spacelabs-healthcare-medical-equipment-suzhou)
- Schiller AG: 1 (https://510kreport.com/company/schiller)
- Cas Medical Systems, Inc.: 1 (https://510kreport.com/company/cas-medical-systems)
- Invivo Corporation: 1 (https://510kreport.com/company/invivo)

## Its most-cited devices
- K001775: Zoe Medical Nightingale Monitoring System (2001), cited by 3
- K130740: Nightingale Monitoring System (2013), cited by 2
- K040012: Well@Home System (2004), cited by 1

## Recent decisions
- K200160: 740 SafeSAT (Feb 15, 2021)
- K130740: Nightingale Monitoring System (Jul 23, 2013)
- K093802: Ultraview DM3 Monitor (Apr 9, 2010)
- K040012: Well@Home System (Apr 2, 2004)
- K001775: Zoe Medical Nightingale Monitoring System (Jan 12, 2001)

Source page: https://510kreport.com/company/zoe-medical