# K071895: Verify 275 Degree F. 3-10 Indicator; 10 Indicator; 3 Indicator

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Nov 14, 2007 after 128 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: 2 generations back to K801109 (1980). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894399: Sterigage Integrator Test Pack for Steam Sterili., Pymah Corp. (1989) Summary page 2.
- 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.
- K902958: TST Control Integrator for Steam Autoclave, Board of Directors, Albert Browne, Ltd. (1990) Summary page 2.
- K002937: TST Control Integrator for Steam Sterilizers, Albert Browne, Ltd. (2001) Summary page 2.
- K963841: Eztest, Sgm Biotech, Inc. (1997) 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
- K102894: Classix Chemical Sterilization Indicator (2011), 0 descendants of its own

## Indications for use
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: Verify 275F 3; TEMPERATURE: 275°F (135°C); STERILIZATION TYPE: Pre-vacuum steam; TIME: 3 minutes

Source page: https://510kreport.com/device/K071895
Methodology: https://510kreport.com/methodology