Getinge 800HC- Series Steam Sterilizer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K122625 ↗

FDA Product Code

FLE

Device Class

Class II

Regulation

21 CFR Part 880.6880

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Getinge 400HC/500HC Series Steam Sterilizer

  Class II

  FDA 510(k) K103504 Active Cleared 16 Mar 2011

• Getinge 633HC Series Vacuum/Gravity Steam Sterilizer

  Class II

  FDA 510(k) K070657 Active Cleared 5 Apr 2007

• Getinge 633HC Steam Sterilizer Air Glide System

  Class II

  FDA 510(k) K120532 Active Cleared 2 May 2013

• Getinge Series Warming Cabinet

  Class I

  FDA 510(k) K153713 Active Cleared 7 Jun 2016

• Getinge 700HC-E Series Steam Sterilizer

  Class II

  FDA 510(k) K120441 Active Cleared 31 May 2012

• Getinge 400HC-E / Series Steam Sterilizer

  Class II

  FDA 510(k) K122071 Active Cleared 12 Mar 2013

• What types of materials can the Getinge 800HC-E Series Steam Sterilizer effectively sterilize?

  The Getinge 800HC-E Series is designed specifically for heat and moisture-stable materials, such as surgical instruments and linens. Its gravity/downward displacement steam sterilization process, combined with positive pulse conditioning and pressure/vacuum pulsing, ensures thorough air removal and effective sterilization for these types of items.

• How many chamber sizes are available for the Getinge 800HC-E Series, and what are their dimensions?

  The Getinge 800HC-E Series is available in two chamber sizes: a 42-inch long model with a capacity of 39.6 cubic feet, and a 76-inch long model with a capacity of 72.0 cubic feet. These sizes cater to varying healthcare facility needs, allowing for flexibility in sterilization workloads.

• Is the Getinge 800HC-E Series Steam Sterilizer intended for use in specific types of healthcare settings?

  Yes, the device is explicitly intended for use in hospital settings, as indicated by its classification under the General Hospital medical specialty description in the FDA registry. This aligns with its design for high-volume sterilization needs common in acute care environments.

• What regulatory pathway was used for FDA clearance of the Getinge 800HC-E Series, and what does this mean for its intended use?

  The Getinge 800HC-E Series received FDA clearance under the Traditional 510(k) pathway, determined to be *Substantially Equivalent* to a predicate device. This means the FDA reviewed it against an existing, cleared sterilizer and confirmed it meets the same performance standards for sterilizing heat and moisture-stable materials in hospital settings, without implying any new clinical indications.

• How does the sterilizer’s air removal technology benefit the sterilization process?

  The Getinge 800HC-E Series employs *positive pulse conditioning* and *pressure/vacuum pulsing* to actively remove air from the chamber before and during sterilization. This ensures steam can fully penetrate wrapped loads and contact all surfaces of instruments or linens, improving efficacy and reducing the risk of contamination from residual air pockets.