Cleared Special

K251048 - Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251048 · STERIS Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
29d
Days
Class 2
Risk

K251048 is an FDA 510(k) clearance for the Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118. 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 May 2, 2025 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all STERIS Corporation devices

Submission Details

510(k) Number K251048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2025
Decision Date May 02, 2025
Days to Decision 29 days
Submission Type Special
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
99d faster than avg
Panel avg: 128d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 264
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K251048.
LF Process Indicator Tape for Steam Sterilization
K260181 · Intertape Polymer Group · Feb 2026
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016)
K251991 · Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. · Dec 2025
DISINTEK™ PA Test Strips
K251035 · Serim Research · Jun 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
Type 5 Integrating Indicator for Steam (CSPN-15)
K242860 · True Indicating, LLC · Jan 2025