Home / 510(k) Clearances / K093333

510(k) K093333

PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 by Primus Sterilizer Company, LLC — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2010
Date Received
October 26, 2009
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)
  • K221474 — PRIMUS Healthcare Sterilizer (Model PSS11-HC) (February 10, 2023)
  • K082817 — PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M (May 21, 2009)

Other clearances for product code FLE

  • K260254 — Enbio PRO (February 26, 2026)
  • K252307 — Getinge GSS67N Series Steam Sterilizer (January 22, 2026)
  • K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (December 30, 2025)
  • 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)