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510(k) K874659

STERILIZATION OF DEVICES BY RADIATION by Inhalation Plastics — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
October 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Inhalation Plastics

  • K945565 — SPIRO-FLEX (January 13, 1995)
  • K914686 — THERMO-FLOW SET (April 15, 1992)
  • K901315 — AEROMIST II NEBULIZER (September 10, 1990)
  • K900990 — FILT-R-ALL BACTERIAL/VIRAL FILTER (April 19, 1990)
  • K900594 — ANESTHESIA BREATHING CIRCUIT (March 15, 1990)
  • K896832 — FILT-R-ALL BACTERIAL FILTER (January 22, 1990)

Other clearances for product code BTT

  • K251448 — FL-10000U Respiratory Humidifier (January 16, 2026)
  • K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 14, 2026)
  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)