# K973225: Castle Series 200 Steam Sterilizer (Powerclave)

- Pathway: 510(k) (Traditional)
- Applicant: Getinge/Castle, Inc.
- Decided: Feb 10, 1998 after 167 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.
No later device cites it as a predicate yet.
0 of 2 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 2.

## Indications for use
Indoor Use Only Model 222: The Castle Model 222 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. Unwrapped goods cycles (flash) are used to process unwrapped hard goods such as instruments and utensils. Steam sterilization by the unwrapped (flash) method is employed when time does not permit the use of the preferable, wrapped sterilization procedure. Implantables should never be sterilized by the unwrapped (flash) method. All cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures range from 250°F to 275°F (121°C to 135°C) The cycles to be cleared for this model (Model 222) are: Exposure Dry Cycle Name Type Temp Minutes Minutes ~- P1 GRAVWRAP 1 Gravity 250°F 250°F 30 30 P2 GRAV WRAP 2 Gravity 275°F 275°F 10 30 P3 FLASH3+ Gravity 3 Minutes 275°F 3 0 P4 FLASH 10+ Gravity 10 Minutes 275°F 10 0 Model 233: The Castle Model 233 Vacuum Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped hard goods and linens. Wrapped-goods (Hi Vac) cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. A gravity cycle is provided for processing wrapped dry goods and/or hard goods. Additionally, a Vacuum Leak Test cycle, not intended for sterilization, and an Air-Removal-Test-Pack (Bowie-Dick) cycle, not intended for sterilization is provided. The wrapped-goods (Hi Vac) cycles employ vacuum-and-positive pulsing to condition a load before processing at the selected exposure temperature. The gravity cycle employs the gravity, or downward displacement method of air removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C). The cycles to be cleared for this model (Model 233) are: Exposure Dry Cycle Name Type Temp Minutes Minutes P1 PREVACONE Prevac275°F 275°F 3 16 P2 PREVACTWO Prevac275°F 275°F 3 3 P3 GRAVITY WRAP ' Gravity 250°F ~'250°F " ~7"30 "~~~ 730 i P5 B-DTEST Air Removal 273°F 3.5 0} P6 VACLEAKTST Vacuumleak 268°F 3 15(dry)+5(dwell)+15(test) Model 223: The Castle Model 223 Gravity Steam Sterilizer is intended for steam sterilization of hospital supplies. Typical clinical (Hospital) applications include wrapped and unwrapped hard goods and linens. Wrapped-goods cycles are provided for processing wrapped linen packs, as well as wrapped hard goods such as instruments and utensils. The cycles employ gravity or downward displacement with positive pulsing conditioning for dynamic air removal. Processing temperatures for wrapped goods cycles range from 250°F to 275°F (121°C to 135°C). The cycles to be cleared for this model (Model 223) are: Exposure Dry Cycle Name Type Temp Minutes Minutes P1 GRAV WRAP 1 Gravity 250°F 250°F 30 30 P2 GRAV WRAP 2 Gravity 275°F 275°F 10 30 All Models: Castle Series 200 Steam Sterilizers are programmed with factory recommended sterilization parameters (cycle settings) which have been verified and validated for efficacy. By using a supervisory password, the controls allow for flexibility in selecting exposure temperature, exposure time, and drying time. It is possible, with that password, to select cycle settings that will not necessarily achieve the desired sterility assurance level. Users with password access are responsible for the efficacy of any cycle settings other than the factory recommended settings.

Source page: https://510kreport.com/device/K973225
Methodology: https://510kreport.com/methodology