Cleared Special

CELERITY HP Indicator Tape

K240760 · Steris · General Hospital
Apr 2024
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K240760 is an FDA 510(k) clearance for the CELERITY HP Indicator Tape, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on April 10, 2024, 21 days after receiving the submission on March 20, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K240760 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2024
Decision Date April 10, 2024
Days to Decision 21 days
Submission Type Special
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