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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 a medical device manufactured by Advanced Sterilization Products, Inc.. It received FDA 510(k) clearance on 2026-04-15 under approval 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. It is manufactured by Advanced Sterilization Products, Inc.. The 510(k) number is K252843.

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

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

What company makes STERRAD 100NX Sterilization System with ALLClear Technology (10104)?

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

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.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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) K250802STERRAD® 100NX Sterilizer 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

View on FDA Database →

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