Home / 510(k) Clearances / K050381

510(k) K050381

CS MEDICAL TTCF GAS DELIVERY SYSTEM by Cs Medical, Inc. — Product Code BZR

K050381 is an FDA 510(k) premarket notification submitted by Cs Medical, Inc. for the device "CS MEDICAL TTCF GAS DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 13, 2005. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Cs Medical, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2005
Date Received
February 15, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

Other clearances by Cs Medical, Inc.

  • K233049 — TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with (November 21, 2023)
  • K230381 — Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High- (June 7, 2023)
  • K192228 — CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD- (April 1, 2020)
  • K182891 — TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and (April 12, 2019)
  • K160921 — CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Me (November 3, 2016)
  • K051305 — CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL TD (August 18, 2005)
  • K050379 — CS MEDICAL ADULT TTCF CATHETER (July 12, 2005)

Other clearances for product code BZR

  • K243917 — F&P Optiflow Air/Oxygen Flow Source (July 14, 2025)
  • K241465 — Midas Flowmeter; eAVS (September 19, 2024)
  • K231895 — Maxtec MaxBlend2+p (December 4, 2023)
  • K230987 — FlowStar Analog Mixer Flowmeter (September 14, 2023)
  • K222794 — FlowStar Touch Digital Mixer Flowmeter (July 28, 2023)
  • K221494 — Quality Mix Blender, Oxymixer (January 23, 2023)
  • K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (April 22, 2021)
  • K173205 — Equinox Advantage (August 29, 2018)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)

FDA data resources