Steris - FDA 510(k) Cleared Devices

Not Cleared May 01, 2026

Prolystica Pass Thru Disinfectant Wipes

DEN240075 · SHM

General Hospital · 505d

Cleared Jun 06, 2025

Celerity 5 HP Biological Indicator (LCB052)

K251452 · FRC

General Hospital · 28d

Not Cleared Nov 12, 2024

VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

DEN230085 · SDC

General Hospital · 330d

Cleared Aug 20, 2024

CELERITY HP Indicator Tape (PCC077)

K242189 · JOJ

General Hospital · 26d

Cleared Jun 11, 2024

MetriCide™ OPA Plus Solution Test Strip

K241344 · JOJ

General Hospital · 29d

Cleared Apr 10, 2024

CELERITY HP Indicator Tape

K240760 · JOJ

General Hospital · 21d

Cleared Dec 08, 2023

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical...

K233654 · JOJ

General Hospital · 24d

Cleared Oct 27, 2023

Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078)

K233187 · JOJ

General Hospital · 29d

Cleared Oct 20, 2023

V-PRO maX 2 Low Temperature Sterilization System

K233065 · MLR

General Hospital · 24d

Cleared Sep 13, 2023

AMSCO 600 Steam Sterilizer

K232485 · FLE

General Hospital · 28d

Cleared Aug 07, 2023

Celerity™ HP Chemical Indicator

K231488 · JOJ

General Hospital · 76d

Cleared Sep 30, 2022

AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...

K222849 · NVE

General Hospital · 9d