Cleared Abbreviated

EO Chex Indicator Tape

K240910 · Propper Manufacturing Co., Inc. · General Hospital
Jun 2024
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K240910 is an FDA 510(k) clearance for the EO Chex Indicator Tape, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on June 12, 2024, 71 days after receiving the submission on April 2, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K240910 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2024
Decision Date June 12, 2024
Days to Decision 71 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

Similar Devices — JOJ Indicator, Physical/chemical Sterilization Process

All 264
LF Process Indicator Tape for Steam Sterilization
K260181 · Intertape Polymer Group · Feb 2026
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
K251991 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Dec 2025
DISINTEK? PA Test Strips
K251035 · Serim Research · Jun 2025
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · STERIS Corporation · May 2025
VERIFY STEAM Integrating Indicator
K243876 · STERIS Corporation · Apr 2025
Green Card Bowie-Dick Test (BD115)
K250172 · Steritec Products, Inc. (A Getinge Company) · Feb 2025