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FDA 510(k)

STERRAD 100NX Sterilization System with ALLClear Technology (10104)

K-Number: K252843 · 2026-04-15

ApplicantAdvanced Sterilization Products, Inc.
Decision Date2026-04-15
Product CodeMLR
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERRAD 100NX Sterilization System with ALLClear Technology (10104) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K252843. 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 Sterilization System with ALLClear Technology (10104)?

STERRAD 100NX Sterilization System with ALLClear Technology (10104) is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Advanced Sterilization Products, Inc.. The 510(k) number is K252843.

When did STERRAD 100NX Sterilization System with ALLClear Technology (10104) receive FDA 510(k) clearance?

STERRAD 100NX Sterilization System with ALLClear Technology (10104) received FDA 510(k) clearance on 2026-04-15, under 510(k) number K252843.

Who is the listed applicant for STERRAD 100NX Sterilization System with ALLClear Technology (10104)?

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

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

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

Other records listing Advanced Sterilization Products, Inc. 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.

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 TechnologyK163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator

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.

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 SystemSterisK223476V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation

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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