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510(k) K871386

BREATHING CIRCUIT by Dryden Corp. — Product Code CAI

K871386 is an FDA 510(k) premarket notification submitted by Dryden Corp. for the device "BREATHING CIRCUIT". The FDA issued a decision of Substantially Equivalent on May 29, 1987. The device falls under product code CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece)), a Class I device regulated under 21 CFR 868.5240. Dryden Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1987
Date Received
April 7, 1987
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 Dryden Corp.

  • K880923 — PATIENT VENTILATOR ISOLATOR (September 6, 1988)
  • K880769 — BREATHING CIRCUIT W/HEATED WIRE (August 24, 1988)
  • K882285 — NONREBREATHING CIRCUIT (August 16, 1988)
  • K873928 — UNIVERSAL TOURNIQUET (October 23, 1987)
  • K873927 — REUSEABLE BREATHING TUBES (October 20, 1987)
  • K870859 — BAG-TAIL BLEED VALVE (August 3, 1987)
  • K870858 — BADGWELL SAMPLING CATHETER (May 14, 1987)
  • K861540 — DISPOSABLE BERMAN AND GUEDEL AIRWAYS (May 2, 1986)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)
  • K842843 — DRYDEN SCAVENGER INTERFACE SYSTEM (July 27, 1984)

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