# Waters Medical Systems, LLC

- Location (FDA's records): Rochester, MN
- FDA decisions: 3 (2012–2013): 3 510(k) clearances
- Product codes: KDL (2), KDN (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 4 (0 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
- Trans-Med Corp.: 1 (https://510kreport.com/company/trans-med)

## Firms that cite its devices most
- Institut Georges Lopez: 2 (https://510kreport.com/company/institut-georges-lopez)
- Xvivo Perfusion AB: 1 (https://510kreport.com/company/xvivo-perfusion)
- S.A.L.F. Spa: 1 (https://510kreport.com/company/salf)

## Its most-cited devices
- K121736: Perf-Gen Pulsatile Perfusion Solution (2013), cited by 2
- K121618: Bel-Gen Cold Storage Solution (2013), cited by 1
- K111521: WAVES (2012), cited by 1

## Recent decisions
- K121736: Perf-Gen Pulsatile Perfusion Solution (Aug 16, 2013)
- K121618: Bel-Gen Cold Storage Solution (Jun 14, 2013)
- K111521: WAVES (Feb 16, 2012)

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