# Simplisse, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 1 (2010–2010): 1 510(k) clearance
- Product codes: HGX (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 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
- Medela AG: 1 (https://510kreport.com/company/medela)
- Ameda Medizintechnik AG: 1 (https://510kreport.com/company/ameda-medizintechnik)
- Evenflo Company, Inc.: 1 (https://510kreport.com/company/evenflo)

## Recent decisions
- K093648: Simplisse Electric Breastfeeding Companion (Jul 14, 2010)

Source page: https://510kreport.com/company/simplisse