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510(k) K900594

ANESTHESIA BREATHING CIRCUIT by Inhalation Plastics — Product Code CAI

K900594 is an FDA 510(k) premarket notification submitted by Inhalation Plastics for the device "ANESTHESIA BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on March 15, 1990. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Inhalation Plastics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1990
Date Received
February 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device Class
Class I
Regulation Number
868.5240
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)
  • K896832 — FILT-R-ALL BACTERIAL FILTER (January 22, 1990)
  • K874659 — STERILIZATION OF DEVICES BY RADIATION (February 2, 1988)

Other clearances for product code CAI

  • K954480 — CONDENSATE COLLECTION KIT (December 29, 1995)
  • K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT (September 19, 1995)
  • K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS (September 19, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952009 — PRIMA PEDIATRIC TEMPERATURE MONITORING CIRCUITS (May 19, 1995)

FDA data resources