# SmartWise Sweden AB

- Location (FDA's records): Tullinge, SE
- FDA decisions: 2 (2022–2026): 2 510(k) clearances
- Product codes: KRA (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 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
- Mercator Medsystems, Inc.: 1 (https://510kreport.com/company/mercator-medsystems)

## Its most-cited devices
- K213442: Extroducer Infusion Catheter System (2022), cited by 1

## Recent decisions
- K254051: Extroducer Infusion Catheter System (Sep 11, 2026)
- K213442: Extroducer Infusion Catheter System (Jun 10, 2022)

Source page: https://510kreport.com/company/smartwise-sweden