# K240910: EO Chex Indicator Tape

- Pathway: 510(k) (Abbreviated)
- Applicant: Propper Manufacturing Co., Inc.
- Decided: Jun 12, 2024 after 71 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 K002861 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002861: EO Gas Sterilization Process Indicator Tapes, Model CI 124, Steritec Products, Inc. (2000) Summary page 6.

## Indications for use
The EO Chex Indicator Tape for Ethylene Oxide gas sterilization is designed to secure wrapped packs by a health care provider. EO Chex indicator tape demonstrates that the packs have been exposed to an EO gas sterilization process, and to distinguish between processed and unprocessed packs. The EO process indicator turns from pink to orange-brown when exposed to EO gas sterilization conditions, thus providing an indication of processed items. The EO Chex indicator tape can be used in the following EO sterilization cycles: 1. 38°C, 736 mg/L EO, 40-80% RH, 4.5 hours exposure 2. 38°C, 759 mg/ L EO, 40-80% RH, 4.5 hours exposure 3. 54°C, 600 mg/ L EO, 40-60% RH, 45 min or longer 4. 55°C, 736 mg/ L EO, 40-80% RH, 1 hour exposure 5. 55°C, 759 mg/ L EO, 40-80% RH, 1 hour exposure Performance The performance of the EO Chex indicator tape meets the requirements of ANSI/AAMI/ISO 11140-1:2014 for Type 1 process indicators. Stated Values Temperature: 37°C, RH: 60%, Time: 25min, EO: 600mg/L Temperature: 54°C, RH: 60%, Time: 20min, EO: 600mg/L

Source page: https://510kreport.com/device/K240910
Methodology: https://510kreport.com/methodology