# Getinge USA, Inc.

- Location (FDA's records): Rochester, NY
- FDA decisions: 4 (2003–2005): 4 510(k) clearances
- Product codes: FRC (2), JOJ (1), FLE (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (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 whose devices it cites most
- Getinge/Castle, Inc.: 2 (https://510kreport.com/company/getinge-castle)
- Mdt Corp., Inc.: 1 (https://510kreport.com/company/mdt)
- Steritec Products, Inc.: 1 (https://510kreport.com/company/steritec-products)
- Clinical Technology Corp.: 1 (https://510kreport.com/company/clinical-technology)

## Recent decisions
- K050664: Spor-Test PA Biological Indicator Kit (Apr 7, 2005)
- K032723: Biosign Steam-24 Biological Indicator (Oct 1, 2003)
- K031647: Biosign Ssi Biological Test Pack with Instant Readout Integrator (Jul 29, 2003)
- K031259: Model 833HC Vacuum/Gravity Steam Sterilizer (May 12, 2003)

Source page: https://510kreport.com/company/getinge-usa