FDA 510(k)

STERRAD® 100NX Sterilizer with ALLClear Technology (10104)

K-Number: K250802 · 2025-04-14

ApplicantAdvanced Sterilization Products, Inc.

Decision Date2025-04-14

Product CodeMLR

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERRAD® 100NX Sterilizer with ALLClear Technology (10104) is a medical device manufactured by Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2025-04-14 under approval number K250802. 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® 100NX Sterilizer with ALLClear Technology (10104)?

STERRAD® 100NX Sterilizer with ALLClear Technology (10104) is a medical device that received FDA 510(k) clearance on 2025-04-14. It is manufactured by Advanced Sterilization Products, Inc.. The 510(k) number is K250802.

When was STERRAD® 100NX Sterilizer with ALLClear Technology (10104) approved by the FDA?

STERRAD® 100NX Sterilizer with ALLClear Technology (10104) received FDA 510(k) clearance on 2025-04-14, under approval number K250802.

What company makes STERRAD® 100NX Sterilizer with ALLClear Technology (10104)?

STERRAD® 100NX Sterilizer with ALLClear Technology (10104) is manufactured by Advanced Sterilization Products, Inc..

What is the FDA product code for STERRAD® 100NX Sterilizer with ALLClear Technology (10104)?

The FDA product code for STERRAD® 100NX Sterilizer with ALLClear Technology (10104) is MLR.

Other Devices by Advanced Sterilization Products, Inc.

K212174STERRAD 100NX Sterilizer with ALLClear Technology K220404STERRAD NX 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) K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Related Devices (Code: MLR)

K160818STERRAD® NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization SystemSTERIS Corporation K162007STERRAD NX SterilizerAdvanced Sterilization Products

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.