# K012195: Steam Sterilization Intergrator

- Pathway: 510(k) (Traditional)
- Applicant: Dana Products, Inc.
- Decided: May 7, 2002 after 298 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
No predicates in its family tree.
10 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152630: VERIFY STEAM Integrating Indicator (2016), 5 descendants of its own
- K162631: VERIFY STEAM Integrating Indicator - Short (2017), 2 descendants of its own
- K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator (2007), 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

## Indications for use
Dana Steam Sterilization Integrators are intended to be used to monitor critical parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (when steam is present). The end point is determined by the migration of the steam sensitive dye to an area marked safe on the indicator. The integrators are intended to be used in 30 minute gravity cycles at 250 degrees F and 3 minute gravity and pre- vacuum cycles at 270 degrees F.

Source page: https://510kreport.com/device/K012195
Methodology: https://510kreport.com/methodology