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510(k) K023290

STERRAD 50 & STERRAD 100S STERILIZERS by Advanced Sterilization Products — Product Code FLF

K023290 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD 50 & STERRAD 100S STERILIZERS". The FDA issued a decision of Substantially Equivalent on April 3, 2003. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2003
Date Received
October 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Advanced Sterilization Products

  • K252843 — STERRAD 100NX Sterilization System with ALLClear Technology (10104) (April 15, 2026)
  • K250802 — STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) (April 14, 2025)
  • K234084 — STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indi (July 5, 2024)
  • K234082 — STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); (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)

Other clearances for product code FLF

  • K192978 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 12, 2020)
  • K170432 — Anprolene AN75 Ethylene Oxide Gas Sterilizer (October 31, 2017)
  • K150646 — EOGas 4 Ethylene Oxide Gas Sterilizer (November 18, 2015)
  • K142034 — 3M STERI-VAC STERILIZER/AERATOR (January 8, 2015)
  • K090636 — TSO3 OZONE STERILIZER, MODEL 125L (December 2, 2009)
  • K051595 — TSO3 OZONE STERILIZER, MODEL 125L (July 26, 2006)
  • K020875 — TSO3 OZONE STERILIZER, MODEL 125L (August 26, 2003)
  • K014013 — H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM (June 25, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)
  • K923442 — ABTOX PLAZLYTE PROCESS MONITOR (December 22, 1994)

FDA data resources