# K243876: VERIFY STEAM Integrating Indicator

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Apr 25, 2025 after 128 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: 4 generations back to K012195 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213412: VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM, Steris Corparation (2022) Summary page 6.

## Indications for use
The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device 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, 4 minutes Dynamic Air Removal • 270°F/132°C, 5 minutes Dynamic Air Removal • 270°F/132°C, 6 minutes Dynamic Air Removal • 270°F/132°C, 7 minutes Dynamic Air Removal • 270°F/132°C, 8 minutes Dynamic Air Removal • 270°F/132°C, 9 minutes Dynamic Air Removal • 270°F/132°C, 10 minutes Dynamic Air Removal • 270°F/132°C, 15 minutes Gravity • 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 (IUSS): • 270°F/132°C, 4 minutes Dynamic Air Removal • 270°F/132°C, 3 minutes Gravity • 270°F/132°C, 10 minutes Gravity • 275°F/135°C, 3 minutes Dynamic Air Removal • 275°F/135°C, 3 minutes Gravity • 275°F/135°C, 10 minutes Gravity

Source page: https://510kreport.com/device/K243876
Methodology: https://510kreport.com/methodology