# Ectosense NV

- Location (FDA's records): Rotselaar, BE
- FDA decisions: 3 (2020–2022): 3 510(k) clearances
- Product codes: MNR (3)
- 510(k) review time since 2016: median 50 days, against 192 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 5 (2 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
- Itamar Medical, Ltd.: 1 (https://510kreport.com/company/itamar-medical)

## Firms that cite its devices most
- Happy Health, Inc.: 1 (https://510kreport.com/company/happy-health)
- Pranaq Pte., Ltd.: 1 (https://510kreport.com/company/pranaq)
- Belun Technology Company Limited: 1 (https://510kreport.com/company/belun-technology)

## Its most-cited devices
- K191031: NightOwl (2020), cited by 2
- K220028: NightOwl (2022), cited by 2
- K213463: NightOwl (2021), cited by 1

## Recent decisions
- K220028: NightOwl (Feb 24, 2022)
- K213463: NightOwl (Dec 16, 2021)
- K191031: NightOwl (Mar 6, 2020)

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