Cleared Traditional

K240032 - Celerity Chemical Indicator for enspire...

K240032 is the FDA 510(k) clearance for Celerity Chemical Indicator for enspire... by STERIS Corporation. It is a Class 2 General Hospital device (product code JOJ) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K240032 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
104d
Days
Class 2
Risk

K240032 is an FDA 510(k) clearance for the Celerity Chemical Indicator for enspire 3000 CLCSPS. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 17, 2024 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all STERIS Corporation devices

Submission Details

510(k) Number K240032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2024
Decision Date April 17, 2024
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOJ Indicator, Physical/chemical Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOJ Indicator, Physical/chemical Sterilization Process

All 114
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K240032.
EO Chex Indicator Tape
K240910 · Propper Manufacturing Co., Inc. · Jun 2024
MetriCide™ OPA Plus Solution Test Strip
K241344 · Steris · Jun 2024
3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190
DEN230068 · 3M Company · May 2024
CELERITY HP Indicator Tape
K240760 · Steris · Apr 2024
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
K233654 · Steris · Dec 2023
Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)
K233187 · Steris · Oct 2023