Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K192001 ↗

FDA Product Code

FRC

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sterilucent Sterilization Container System

  Class II

  FDA 510(k) K142109 Active Cleared 20 Jan 2015

• Sterilucent Self-Contained Biological Indicator

  Class II

  FDA 510(k) K141238 Active Cleared 3 Nov 2014

• Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

  Class II

  FDA 510(k) K190005 Active Cleared 13 Sep 2019

• Sterilucent Process Challenge Device

  Class II

  FDA 510(k) K141312 Active Cleared 31 Oct 2014

• Sterilucent VH2O2 Chemical Indicators

  Class II

  FDA 510(k) K191999 Active Cleared 21 Oct 2019

• Sterilucent Psd-85 Hydrogen Peroxide Sterilizer

  Class II

  FDA 510(k) K140464 Active Cleared 31 Oct 2014