# Exini Diagnostics AB

- Location (FDA's records): Lund, SE
- FDA decisions: 4 (2012–2022): 4 510(k) clearances
- Product codes: LLZ (4)
- 510(k) review time since 2016: median 60 days, against 116 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 5 (3 its own); citations of its devices by later devices: 4 (3 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
- Medqia: 1 (https://510kreport.com/company/medqia)
- Keosys Sas: 1 (https://510kreport.com/company/keosys)

## Firms that cite its devices most
- Aiq Solutions, Inc.: 1 (https://510kreport.com/company/aiq-solutions)

## Its most-cited devices
- K122205: EXINI (2012), cited by 2
- K211655: aPROMISE (2021), cited by 1
- K191262: aBSI (2019), cited by 1

## Recent decisions
- K220590: aPROMISE X (Apr 29, 2022)
- K211655: aPROMISE (Jul 27, 2021)
- K191262: aBSI (Aug 5, 2019)
- K122205: EXINI (Aug 15, 2012)

Source page: https://510kreport.com/company/exini-diagnostics