# K070895: Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10 Challenge Pack

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Sep 5, 2007 after 159 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: 1 generation back to K002741 (2002). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002741: Browne TST Single Use Bowie Dick/Integrator Test Pack, Albert Browne, Ltd. (2002) Summary page 2.

## Most influential descendants
- K073683: Verify Challenge Packs - Version 2 (2008), 2 descendants of its own
- 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 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: MODEL TEMPERATURESTERILiZATIONTYPE TIME Verify® 270F 4 270°F (132°C) Pre-vacuum, Steam Flush 4 minutes Pressure Pulse (SFPP) Verify® 275F 3 275 0 F (135°C) Pre-vacuum 3 minutes

Source page: https://510kreport.com/device/K070895
Methodology: https://510kreport.com/methodology