Home / 510(k) Clearances / K221227

510(k) K221227

Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 by Tuttnauer , Ltd. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2022
Date Received
April 28, 2022
Clearance Type
Traditional
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 Tuttnauer , Ltd.

  • K222608 — Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS (December 16, 2022)
  • K213080 — T-Edge 10, T-Edge 11 (January 4, 2022)
  • K181456 — Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves (July 8, 2019)

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)