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510(k) K221474

PRIMUS Healthcare Sterilizer (Model PSS11-HC) by Primus Sterilizer Company, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 2023
Date Received
May 20, 2022
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type

Other clearances by Primus Sterilizer Company, LLC

  • K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (December 19, 2023)
  • K093333 — PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO S (April 2, 2010)
  • K082817 — PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M (May 21, 2009)

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  • K250164 — Cassette Autoclave (ACA5) (August 14, 2025)
  • K243994 — Steam Sterilizer (2545D) (June 6, 2025)
  • K243801 — FRONT-LINE Field Sterilizer (FL135) (March 7, 2025)
  • K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer (April 4, 2024)
  • K233504 — Lexa MINI (RIS-303, RIS-305) (February 8, 2024)
  • K233132 — PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (December 19, 2023)
  • K232658 — T-Top 10 & T-Top T-Top 11 (November 27, 2023)