# K251991: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Safesecure Medical Infection Control Tech Co., Ltd.
- Decided: Dec 23, 2025 after 179 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: 3 generations back to K932129 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220564: 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355, 3M Company (2022) Summary page 6.
- K191021: Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye, Terragene S.A. (2019) Summary page 13.

## Indications for use
The SafeSecure Steam Sterilization Process Indicators are chemical process indicators intended for use by healthcare professionals to accompany individual units (e.g., wrapped packs) and to demonstrate that the unit has been exposed to a steam sterilization process. The indicator changes color to signal exposure to sterilization conditions. The indicators are validated for use in the following saturated steam sterilization cycles: Sterilization Type Temperature Time Gravity 250 °F/121°C 30 minutes Gravity 270 °F/132°C 3, 4, 10, 15, 25 minutes Gravity 275 °F/135°C 3, 10 minutes Dynamic air-removal 250 °F/121°C 15, 20, 30 minutes Dynamic air-removal 270 °F/132°C 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes Dynamic air-removal 273 °F/134°C 3, 3.5, 4 minutes Dynamic air-removal 275 °F/135°C 4, 10 minutes The product includes both label and tape indicator. The labels can be printed or written on prior to application. The tapes are designed to adhere to common sterilization wraps, including untreated woven, non-woven, paper, and paper/ plastic wraps. The SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicators are chemical process indicators intended to accompany individual packages and visually confirm that the pack has been exposed to a validated Vaporized Hydrogen Peroxide sterilization cycle. The indicator changes color to signal exposure to sterilization conditions. The indicators are validated for use in the following Vaporized Hydrogen Peroxide sterilization systems: ● Standard Cycle of STERRAD® 100S ● Standard cycle and Advanced cycle of STERRAD® NX ● Standard cycle, Flex cycle and Express cycle of STERRAD® 100NX ● Non Lumen Cycle, Lumen Cycle and Flexible Cycle of V-PRO® maX The product includes both label and card indicator. The labels can be printed or written on prior to application. The card is designed to be placed inside the sterilization package, next to the items being sterilized.

Source page: https://510kreport.com/device/K251991
Methodology: https://510kreport.com/methodology