Medical Device Manufacturer · US , Irvin , CA

Advanced Sterilization Products, Inc.

4 submissions · 4 cleared · Since 2021
4
Total
4
Cleared
0
Denied

Advanced Sterilization Products, Inc. — FDA 510(k) Submissions

Advanced Sterilization Products, Inc. has submitted 4 FDA 510(k) premarket notifications since 2021, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Sterilizer, Chemical, Indicator, Physical/chemical Sterilization Process . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
STERRAD? 100NX Sterilizer with ALLClear? Technology (10104)
K250802 · MLR Sterilizer, Chemical · General Hospital
Apr 2025 31d
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)
K234084 · JOJ Indicator,... · General Hospital
Jul 2024 196d
STERRAD NX with ALLClear Technology
K220404 · MLR Sterilizer, Chemical · General Hospital
May 2022 91d
STERRAD 100NX Sterilizer with ALLClear Technology
K212174 · MLR Sterilizer, Chemical · General Hospital
Oct 2021 89d
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