# K242795: Getinge Assured MI Steam Migrating Integrator

- Pathway: 510(k) (Special)
- Applicant: Steritec Products Mfg. (A Getinge Group Company)
- Decided: Oct 15, 2024 after 29 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K012195 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200252: Getinge Assured MI Steam Migrating Integrator, Steritec Products Mfg Co, Inc. (2020) Summary page 6.

## Indications for use
The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles: Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 10 minutes Dynamic Air Removal 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 273°F/134°C, 3 minutes Dynamic Air Removal 273°F/134°C, 4 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal IUSS 270°F/132°C, 3 minutes Gravity IUSS 270°F/132°C, 10 minutes Gravity IUSS 275°F/135°C, 3 minutes Dynamic Air Removal IUSS 275°F/135°C, 3 minutes Gravity IUSS 275°F/135°C, 10 minutes Gravity IUSS Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 2.4 minutes at 134°C 1.5 minutes at 135°C

Source page: https://510kreport.com/device/K242795
Methodology: https://510kreport.com/methodology