Getinge 633HC Steam Sterilizer Air Glide System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K120532 ↗

FDA Product Code

PEC

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 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 800HC- Series Steam Sterilizer

  Class II

  FDA 510(k) K122625 Active Cleared 22 May 2013

• Getinge 400HC-E / Series Steam Sterilizer

  Class II

  FDA 510(k) K122071 Active Cleared 12 Mar 2013

• What types of sterilizers can be connected to the Air Glide System?

  The Air Glide System is compatible with Getinge Model 633HC steam sterilizers that are 51 inches wide and configured with double‑door, pass‑through designs. It can link to between two and seven of these units, allowing a hospital to scale the automation according to its instrument processing volume.

• How does the system improve workflow in a hospital setting?

  By providing a single‑point user interface, a loading conveyor, transport shuttles, and an unloading conveyor, the system eliminates manual handling of instrument trays. This reduces staff time, minimizes the risk of contamination during transfer, and speeds the overall sterilization cycle, leading to higher throughput and more efficient use of operating‑room time.

• Is the Air Glide System a single‑use device or reusable equipment?

  The Air Glide System is a reusable, durable piece of equipment designed for long‑term use in a hospital environment. Its mechanical components such as conveyors and shuttles are built for repeated cycles, and routine maintenance follows the manufacturer’s service guidelines rather than a single‑use disposal model.

• What regulatory pathway was used for this device?

  The system was cleared through the FDA 510(k) process under submission number K120532, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as a Class II device under product code PEC.