# Ardo Medical AG

- Location (FDA's records): Unteraegeri, CH
- FDA decisions: 6 (2001–2023): 6 510(k) clearances
- Product codes: HGX (5), BTA (1)
- 510(k) review time since 2016: median 145 days, against 167 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 7 (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
- Medela AG: 3 (https://510kreport.com/company/medela)
- Egnell, Inc.: 1 (https://510kreport.com/company/egnell)

## Firms that cite its devices most
- Nantong Poly Technology Co., Ltd.: 1 (https://510kreport.com/company/nantong-poly-technology)

## Its most-cited devices
- K141742: Ardo Carum and Calypso Powered Breast Pumps (2014), cited by 3
- K212773: ARDO Alyssa (2022), cited by 1

## Recent decisions
- K230590: ARDO Bellis (Mar 30, 2023)
- K212773: ARDO Alyssa (Apr 15, 2022)
- K172067: One Mum Pumpset (Nov 29, 2017)
- K150721: ARDO Calypso Pro Powered Breast Pump (Jun 17, 2015)
- K141742: Ardo Carum and Calypso Powered Breast Pumps (Oct 17, 2014)
- K011601: Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX (Jun 8, 2001)

Source page: https://510kreport.com/company/ardo-medical