# Cardioline S.P.A

- Location (FDA's records): Cavareno, TN
- FDA decisions: 4 (2015–2023): 4 510(k) clearances
- Product codes: DRG (2), DPS (2)
- 510(k) review time since 2016: median 229 days, against 229 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 7 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mortara Instrument, Inc.: 3 (https://510kreport.com/company/mortara-instrument)
- Et Medical Devices Spa: 2 (https://510kreport.com/company/et-medical-devices)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)

## Firms that cite its devices most
- Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.: 1 (https://510kreport.com/company/mesi-development-of-medical-devices-mesi-doo)
- Synergen Technology Labs, LLC: 1 (https://510kreport.com/company/synergen-technology-labs)

## Its most-cited devices
- K150289: Cardioline HD+ (2015), cited by 3

## Recent decisions
- K220526: HD+12, HD+15 (May 15, 2023)
- K160746: CARDIOLINE touchECG (Nov 2, 2016)
- K160840: ECG100+, ECG200+ (Aug 12, 2016)
- K150289: Cardioline HD+ (Aug 27, 2015)

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