# Aerocrine AB

- Location (FDA's records): Solna, SE
- FDA decisions: 6 (2003–2015): 5 510(k) clearances and 1 De Novo grant
- Product codes: MXA (6)
- Predicates its devices cite: 5 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Circassia AB: 1 (https://510kreport.com/company/circassia)
- Spirosure, Inc.: 1 (https://510kreport.com/company/spirosure)

## Its most-cited devices
- K072816: Niox Mino (2008), cited by 2
- K101034: Niox Mino Model 09-1000 (2010), cited by 2
- DEN030001: Niox Article NO: 02-1000 (2003), cited by 1
- K150233: NIOX VERO Airway Inflammation Monitor (2015), cited by 1
- K133898: Niox Vero Airway Inflammation Monitor (2014), cited by 1

## Recent decisions
- K150233: NIOX VERO Airway Inflammation Monitor (Feb 26, 2015)
- K133898: Niox Vero Airway Inflammation Monitor (Nov 6, 2014)
- K123683: Niox Panel for Use with the Niox Mino Airway Inflammation Monitor (Dec 27, 2012)
- K101034: Niox Mino Model 09-1000 (Sep 2, 2010)
- K072816: Niox Mino (Mar 3, 2008)
- DEN030001: Niox Article NO: 02-1000 (Apr 30, 2003)

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