# K103053: Verify 270FP Challenge Pack

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Mar 10, 2011 after 146 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: 4 generations back to K932129 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073683: Verify Challenge Packs - Version 2, STERIS Corporation (2008) Summary page 2.
- K080136: Instant Readout Chemical Integrator Challenge Pack, Model LT- 105, Steritec Products, Inc. (2008) Summary page 2.

## Most influential descendants
- 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

## Recalls of this device
- Dec 19, 2013 · Class II · Z-1166-2014: STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.

## Indications for use
The Verify® 270FP Challenge Pack is a test pack consisting of three emulating indicator inks situated on a test sheet surrounded by a steam penetration barrier, intended for use in SFPP (steam-flush pressure-pulse) and pre-vacuum steam sterilization. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270'F (I132 0 C): * 4 minute indicator - SFPP and pre-vacuum steam sterilization for 4 minutes. * 10 minute indicator - Pre-vacuum steam sterilization for 10 minutes. * 20 minute indicator - Pre-vacuum steam sterilization for 20 minutes.

Source page: https://510kreport.com/device/K103053
Methodology: https://510kreport.com/methodology