# K083643: Verify 275F Gravity Indicators

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Aug 7, 2009 after 241 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 K960441 (1997). 3 ancestors in all.
1 later device descends 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)
- K012195: Steam Sterilization Intergrator, Dana Products, Inc. (2002) Summary page 2.
- K960441: Steritec Integraph Model CI-101, Steritec Products Mfg Co, Inc. (1997) Summary page 2.
- K002937: TST Control Integrator for Steam Sterilizers, Albert Browne, Ltd. (2001) 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

## Indications for use
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

Source page: https://510kreport.com/device/K083643
Methodology: https://510kreport.com/methodology