Home / 510(k) Clearances / K251048

510(k) K251048

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 by STERIS Corporation — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2025
Date Received
April 3, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by STERIS Corporation

  • K252680 — Celerity™ 20 HP Biological Indicator (September 24, 2025)
  • K243876 — VERIFY STEAM Integrating Indicator (April 25, 2025)
  • K250842 — PADLOCK CLIP EFTR Kit (00713229) (April 18, 2025)
  • K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
  • K250061 — Celerity Incubator (February 6, 2025)
  • K243475 — Chemical Indicator for enspire CLCSPS (LCC015) (December 4, 2024)
  • K243433 — enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (December 2, 2024)
  • K243075 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000 (November 8, 2024)
  • K242742 — DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (October 11, 2024)
  • K240274 — PADLOCK CLIP EFTR Kit (00713229) (September 17, 2024)

Other clearances for product code JOJ

  • K260181 — LF Process Indicator Tape for Steam Sterilization (February 20, 2026)
  • K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeS (December 23, 2025)
  • K251035 — DISINTEK™ PA Test Strips (June 3, 2025)
  • K243876 — VERIFY STEAM Integrating Indicator (April 25, 2025)
  • K250172 — Green Card Bowie-Dick Test (BD115) (February 20, 2025)
  • K242860 — Type 5 Integrating Indicator for Steam (CSPN-15) (January 17, 2025)
  • K241036 — Autoclave Indicator Tape; EO Indicator Tape (December 17, 2024)
  • K243475 — Chemical Indicator for enspire CLCSPS (LCC015) (December 4, 2024)
  • K242795 — Getinge Assured MI Steam Migrating Integrator (October 15, 2024)
  • K241836 — Kem Medical Lead-free Chemical Indicators for Steam Sterilization (September 30, 2024)