# Waters Instruments, Inc.

- Location (FDA's records): Rochester, MN
- FDA decisions: 12 (1981–2006): 12 510(k) clearances
- Product codes: DQA (3), KDN (2), KPH (1), DYG (1), KNT (1), BZC (1), DXG (1), KDK (1), DPW (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (0 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
- Institut Georges Lopez: 1 (https://510kreport.com/company/institut-georges-lopez)
- Bionostics, Inc.: 1 (https://510kreport.com/company/bionostics)

## Its most-cited devices
- K971571: RM3 Renal Preservation System--Control Unit (1997), cited by 1
- K921519: Oxicom-2100 (1992), cited by 1

## Recent decisions
- K053169: RM3 Renal Preservation System (Jan 17, 2006)
- K042224: RM3 Renal Preservation System (Oct 22, 2004)
- K971571: RM3 Renal Preservation System--Control Unit (Jul 29, 1997)
- K921519: Oxicom-2100 (Oct 23, 1992)
- K911207: Oxicomplus (Aug 26, 1991)
- K863210: Velcom-100 (Nov 26, 1986)
- K862161: Osc-80 Oximeter (Aug 18, 1986)
- K852909: MVP - 6000 (Nov 14, 1985)

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