# Getinge/Castle, Inc.

- Location (FDA's records): Rochester, NY
- FDA decisions: 9 (1997–2002): 9 510(k) clearances
- Product codes: FLE (6), FSY (2), FRC (1)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 10 (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
- Sybron Corp.: 2 (https://510kreport.com/company/sybron)
- Mdt Corp., Inc.: 1 (https://510kreport.com/company/mdt)

## Firms that cite its devices most
- Getinge Sourcing, LLC: 2 (https://510kreport.com/company/getinge-sourcing)
- Getinge USA, Inc.: 2 (https://510kreport.com/company/getinge-usa)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)
- Spsmedical Supply Corp.: 1 (https://510kreport.com/company/spsmedical-supply)
- Consolidated Machine Corp.: 1 (https://510kreport.com/company/consolidated-machine)

## Its most-cited devices
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC (2001), cited by 4
- K020205: Castle Peracetic Acid Biological Indicator Kit (2002), cited by 2
- K994314: Castle Series 100HC Steam Sterilizers (2000), cited by 2
- K970907: Castle Series 100 Steam Sterilizers (Straightline) (1997), cited by 1
- K020590: Model 733HC Gravity/Vacuum Steam Sterilizer (2002), cited by 1

## Recent decisions
- K020205: Castle Peracetic Acid Biological Indicator Kit (Jun 24, 2002)
- K020590: Model 733HC Gravity/Vacuum Steam Sterilizer (Mar 20, 2002)
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC (Sep 5, 2001)
- K003441: Castle Model 233HC Steam Sterilizer (Jan 2, 2001)
- K994314: Castle Series 100HC Steam Sterilizers (Feb 16, 2000)
- K993242: Castle Surgical Light, Model 3000 (Nov 8, 1999)
- K974084: Getinge/Castle Optiview Series Surgical Light (Mar 3, 1998)
- K973225: Castle Series 200 Steam Sterilizer (Powerclave) (Feb 10, 1998)

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