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510(k) K252843

STERRAD 100NX Sterilization System with ALLClear Technology (10104) by Advanced Sterilization Products, Inc. — Product Code MLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2026
Date Received
September 8, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Chemical
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Advanced Sterilization Products, Inc.

  • K250802 — STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (April 14, 2025)
  • K234082 — STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); (July 5, 2024)
  • K234084 — STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indi (July 5, 2024)
  • K220404 — STERRAD NX with ALLClear Technology (May 16, 2022)
  • K212174 — STERRAD 100NX Sterilizer with ALLClear Technology (October 9, 2021)
  • K163598 — Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRA (July 31, 2017)
  • K162007 — STERRAD NX Sterilizer (February 16, 2017)
  • K160818 — STERRAD® NX Sterilizer with ALLClear™ Technology (September 27, 2016)
  • K160903 — STERRAD 100NX Sterilizer with ALLClearTM Technology (September 26, 2016)
  • K151725 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (January 13, 2016)

Other clearances for product code MLR

  • K250802 — STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (April 14, 2025)
  • K231893 — LOWTEM Crystal 120 (September 18, 2024)
  • K234082 — STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); (July 5, 2024)
  • K233762 — SteroScope® Sterilization Technology System (June 27, 2024)
  • K233065 — V-PRO maX 2 Low Temperature Sterilization System (October 20, 2023)
  • K223476 — V-PRO maX 2 Low Temperature Sterilization System (August 7, 2023)
  • K231169 — STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK (May 25, 2023)
  • K223015 — STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette (May 9, 2023)
  • K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STE (April 14, 2023)
  • K222093 — V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Ster (September 9, 2022)