# K970907: Castle Series 100 Steam Sterilizers (Straightline)

- Pathway: 510(k) (Traditional)
- Applicant: Getinge/Castle, Inc.
- Decided: Nov 12, 1997 after 246 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820783 (1982). 1 ancestor in all.
24 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820783: Castle Microcomputer Sterilizer Control, Sybron Corp. (1982) Summary page 1.

## Most influential descendants
- K994314: Castle Series 100HC Steam Sterilizers (2000), 23 descendants of its own
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC (2001), 21 descendants of its own
- K030789: Amsco Century Steam Sterilizer (2003), 8 descendants of its own
- K070657: Getinge 633HC Series Vacuum/Gravity Steam Sterilizer (2007), 5 descendants of its own
- K172159: Getinge GSS67N Series Steam Sterilizer (2018), 3 descendants of its own

## Indications for use
The Getinge/Castle Series 100 Steam Sterilizers (Straightline) with the PACS 2000 controls is an upgrade of an existing microcomputer control system for a comprehensive line of health care reusable medical reprocessing equipment. The PACS 2000 controls intended to be used for the control of a variety of equipment including washers, washing/disinfectors, washer/sterilizers and sterilizers. This submittal is made for the PACS 2000 controls applied to the Getinge/Castle (Straightline) line of steam sterilizer models (see attachment Section 18 - Competitive Comparison). The Series 100 (Straightline) sterilizer line includes two sizes, A 16” x 16” x 26” chamber having a volume 3.9 cubic feet and a 20” x 20” x 38” chamber having a volume 8.8 cubic feet. Both chamber sizes include single and double door sterilizers with a power door offered on the single door model only. The Series 100 Steam Sterilizer (Straightline) includes gravity (Model 122) and prevacuum (Model 133) steam sterilizers for healthcare facilities and moist heat (Model 123) sterilizes for laboratories and industrial uses. The latter applications are addressed in this submittal for the rare occasion health care facilities may use them. The to be cleared for each of the models are as follows: For the Model 122 P1 - GRAV WRAP 1 - Gravity Cycle - 30 minute exposure at 250°F and 30 minute dry P2 - GRAV WRAP 2 - Gravity Cycle - 10 minute exposure at 275°F and 30 minute dry P3 - FLASH 3+ - Gravity Cycle with 3 minute exposure at 275°F and 0 minute dry P4 - FLASH 10+ - Gravity Cycle with 10 minute exposure at 275°F and 0 minute dry For the Model 123 P1 - GRAV WRAP 1 - Gravity Cycle - 30 minute exposure at 250°F and 30 minute dry P4 - FLASH 3+ - Gravity Cycle - 3 minute exposure at 275°F and o minutes dry For the Model 133 P1 - PREVA WRAP - Prevacuum Cycle - 3 minute exposure at 275°F and 16 minute dry P2 - PREVA WRP1 - Prevacuum Cycle - 3 minute exposure at 275°F and 3 minute dry P3 - FLASH 3+ - Gravity Cycle - 3 minute exposure at 275°F and 0 minute dry P4 - FLASH 10+ - Gravity Cycle - 10 minute exposure at 275°F and 0 minute dry P5 - VAC LEAK TST - Air leak Test - 3 minute exposure at 268°F and 15 min. leak test

Source page: https://510kreport.com/device/K970907
Methodology: https://510kreport.com/methodology