# Pikdare Spa

- Location (FDA's records): Casnate Con Bernate, IT
- FDA decisions: 2 (2022–2023): 2 510(k) clearances
- Product codes: FMI (2)
- Predicates its devices cite: 2 (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
- Htl-Strefa S.A: 1 (https://510kreport.com/company/htl-strefa-s-a)
- Terumo Europe N.V.: 1 (https://510kreport.com/company/terumo-europe)

## Recent decisions
- K203792: Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle (Jan 20, 2023)
- K223353: DropSafeTM SicuraTM (Dec 2, 2022)

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