# K152630: VERIFY STEAM Integrating Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: May 12, 2016 after 240 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012195 (2002). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012195: Steam Sterilization Intergrator, Dana Products, Inc. (2002) Summary page 6.

## Most influential descendants
- K162631: VERIFY STEAM Integrating Indicator - Short (2017), 2 descendants of its own
- K213412: VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM (2022), 1 descendant of its own
- K200252: Getinge Assured MI Steam Migrating Integrator (2020), 1 descendant of its own
- K243876: VERIFY STEAM Integrating Indicator (2025), 0 descendants of its own
- K242795: Getinge Assured MI Steam Migrating Integrator (2024), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1793-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The integrating indicator is designed to chemically react over time with the critical parameters of 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, 15 minutes Gravity • 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/K152630
Methodology: https://510kreport.com/methodology