Home / 510(k) Clearances / K130263

510(k) K130263

STERRAD 50/100S/200 TEST PACK by Advanced Sterilization Products — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2014
Date Received
February 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

Other clearances by Advanced Sterilization Products

  • 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)
  • K151725 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer (January 13, 2016)

Other clearances for product code FRC

  • K252680 — Celerity™ 20 HP Biological Indicator (September 24, 2025)
  • K251122 — Terragene® Bionova® BT20 Biological Indicator (August 4, 2025)
  • K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (June 6, 2025)
  • K250044 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB05 (February 6, 2025)
  • K250061 — Celerity Incubator (February 6, 2025)
  • K243501 — 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ (January 28, 2025)
  • K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (December 12, 2024)
  • K242538 — 3M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rap (November 25, 2024)
  • K241959 — 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-r (October 18, 2024)
  • K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biono (September 18, 2024)