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MED

Sterilant, Medical Devices

Product code
MED
Device name
Sterilant, Medical Devices
Device class
Class 2
21 CFR
21 CFR 880.6885
Medical specialty
General Hospital
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
64 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-04-08.

NumberDecision dateApplicantDevice nameSummary
K2516662026-04-08STERIS CorporationSYSTEM 1E Liquid Chemical Sterilant Processing Syste…PDF
K2329142023-10-03STERIS CorporationSYSTEM 1E Liquid Chemical Sterilant Processing Syste…PDF

2 summaries are archived here for direct download.

Official FDA classification page: MED
Classification and pathway per current FDA publications. Data from openFDA (CC0).