Home / 510(k) Clearances / K191896

510(k) K191896

Belimed Steam Sterilizer MST-H TOP 5000 by Belimed AG — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2019
Date Received
July 15, 2019
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 Belimed AG

  • K170228 — Belimed Steam Sterilizer MST-H TOP 5000 (May 12, 2017)
  • K130172 — BELIMED STEAM STERILIZER MST-V (September 23, 2013)

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)