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FDA 510(k)

STERRAD® NX Sterilizer with ALLClear™ Technology

K-Number: K160818 · 2016-09-27

ApplicantAdvanced Sterilization Products
Decision Date2016-09-27
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD® NX Sterilizer with ALLClear™ Technology is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K160818. 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 Sterilizer with ALLClear™ Technology?

STERRAD® NX Sterilizer with ALLClear™ Technology is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Advanced Sterilization Products. The 510(k) number is K160818.

When did STERRAD® NX Sterilizer with ALLClear™ Technology receive FDA 510(k) clearance?

STERRAD® NX Sterilizer with ALLClear™ Technology received FDA 510(k) clearance on 2016-09-27, under 510(k) number K160818.

Who is the listed applicant for STERRAD® NX Sterilizer with ALLClear™ Technology?

The FDA 510(k) record lists Advanced Sterilization Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD® NX Sterilizer with ALLClear™ Technology?

The FDA product code for STERRAD® NX Sterilizer with ALLClear™ Technology is MLR.

Other records listing Advanced Sterilization Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)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)K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)K220404STERRAD NX with ALLClear TechnologyK212174STERRAD 100NX Sterilizer with ALLClear Technology

View all 11 devices →

Related Devices (Code: MLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray for ULTRA GI™ Cycle (011077)Advanced Sterilization ProductsK233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.K233065V-PRO maX 2 Low Temperature Sterilization SystemSteris

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.

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