# K073683: Verify Challenge Packs - Version 2

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Jan 25, 2008 after 28 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 K932129 (1994). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070895: Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10 Challenge Pack, STERIS Corporation (2007) Summary page 2.
- K032801: Modified Browne Packaging and Label Steam Process Indicator, Albert Browne, Ltd. (2003) Summary page 2.

## Most influential descendants
- K103053: Verify 270FP Challenge Pack (2011), 1 descendant of its own
- K162758: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (2017), 0 descendants of its own

## Indications for use
The Verify® Challenge Packs -Version 2 -. are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are: Verify 270F 4 270°F (132°C) Pre-vacuum, Steam Flush Pressure Pulse (SFPP) 4 minutes Verify 275F 3 275°F (135°C) Pre-vacuum 3 minutes There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

Source page: https://510kreport.com/device/K073683
Methodology: https://510kreport.com/methodology