# K162758: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 21, 2017 after 172 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: 5 generations back to K932129 (1994). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 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 10.
- K070461: Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4, STERIS Corporation (2007) Summary page 10.
- K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator, STERIS Corporation (2007) Summary page 10.
- K073683: Verify Challenge Packs - Version 2, STERIS Corporation (2008) Summary page 10.
- K083643: Verify 275F Gravity Indicators, STERIS Corporation (2009) Summary page 10.
- K103053: Verify 270FP Challenge Pack, STERIS Corporation (2011) Summary page 10.

## Recalls of this device
- Aug 10, 2022 · Class III · Z-1736-2022: Product contains incorrect chemical indicators in packaging.

## Indications for use
The Verify® Steam Indicators are emulating indicators intended for use in steam sterilization. The Verify® Steam Indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The indicator models and their cycle temperatures, types, and times are: MODEL TEMPERATURE STERILIZATION TYPE TIME Verity 250F 30 250°F (121°C) gravity steam 30 minutes Verify 270F 15 270°F (132°C) gravity steam 15 minutes Verify 270F 3-10 270°F (132°C) gravity flash steam 3 or 10 minutes Verity 270F 4 270°F (132°C) SFPP, pre-vacuum and Express steam 4 minutes The Verify® 275F 3 Indicator is a chemical indicator intended for use by health care providers to accompany products being sterilized through a sterilization procedure. The Verify® 275F 3 Indicator is an emulating indicator intended for use in steam sterilization. The indicator changes color from yellow to blue/purple when exposed to 275°F (135°C) pre-vacuum sterilization cycles for 3 minutes as indicated in the following table: MODEL TEMPERATURE STERILIZATION TYPE TIME Verify 275F 3 275°F (135°C) Pre-vacuum steam 3 minutes The Verify® 275F Gravity Indicators are chemical integrators which meet ANSI/AAMI 1140-1:2005 for emulating indicators intended for use in steam sterilization. The Verify® 275F Gravity Indicators change color from yellow to blue/purple when exposed to 275°F (135°C) and to the appropriate cycle type and duration. The Verify® 275F Indicators models and their cycle types and times are: MODEL TEMPERATURE STERILIZATION TYPE TIME Verify 275F 3-10 275°F (135°C) Gravity flash steam 3 and 10 minutes Verify 275F 10 275°F (135°C) Gravity steam 10 minutes 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). 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 for load release. The Verify® 270FP Challenge Pack indicators change color from yellow to blue/purple when exposed to the following conditions at 270°F (132°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. The Browne TST Dual Use Test Pack is a chemical sterilization process monitor that can be used as either: - Bowie Dick Test - in an empty chamber to monitor air removal and steam penetration during the vacuum stage of 132°C (270°F), 134°C (273°F) , and 135 °C (275 °F) test cycles. - Challenge Pack - in a loaded chamber to monitor steam penetration during the hold/plateau stage of 132°C (270°F), 134 °C (273 °F), and 135 °C (275 °F) steam sterilization cycles.

Source page: https://510kreport.com/device/K162758
Methodology: https://510kreport.com/methodology