STERRAD NX with ALLClear Technology
K-Number: K220404 · 2022-05-16
Decision Date2022-05-16
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
STERRAD NX with ALLClear Technology is a medical device manufactured by Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2022-05-16 under approval number K220404. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the STERRAD NX with ALLClear Technology?
STERRAD NX with ALLClear Technology is a medical device that received FDA 510(k) clearance on 2022-05-16. It is manufactured by Advanced Sterilization Products, Inc.. The 510(k) number is K220404.
When was STERRAD NX with ALLClear Technology approved by the FDA?
STERRAD NX with ALLClear Technology received FDA 510(k) clearance on 2022-05-16, under approval number K220404.
What company makes STERRAD NX with ALLClear Technology?
STERRAD NX with ALLClear Technology is manufactured by Advanced Sterilization Products, Inc..
What is the FDA product code for STERRAD NX with ALLClear Technology?
The FDA product code for STERRAD NX with ALLClear Technology is MLR.
Other Devices by Advanced Sterilization Products, Inc.
K212174STERRAD 100NX Sterilizer with ALLClear Technology
K234084STERRAD 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)
K250802STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)
Related Devices (Code: MLR)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.