Advanced Sterilization Products, Inc. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
STERRAD 100NX Sterilization System with ALLClear Technology (10104)510(k)Apr 15, 2026General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 15, 2026
STERRAD® 100NX Sterilizer with ALLClear Technology (10104)510(k)Apr 14, 2025General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 14, 2025
STERRAD Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY Reader (43220); ULTRA GI Process Challenge Device (PCD) (43400)(30 count)510(k)Jul 5, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jul 5, 2024
STERRAD NX with ALLClear Technology510(k)May 16, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	May 16, 2022
STERRAD 100NX Sterilizer with ALLClear Technology510(k)Oct 9, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 9, 2021