Home / 510(k) Clearances / K840015

510(k) K840015

SWIVEL ADAPTOR W/ALARM PORT by Portex, Inc. — Product Code BZA

K840015 is an FDA 510(k) premarket notification submitted by Portex, Inc. for the device "SWIVEL ADAPTOR W/ALARM PORT". The FDA issued a decision of Substantially Equivalent on January 17, 1984. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Portex, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1984
Date Received
January 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
Review Panel
AN
Submission Type

Other clearances by Portex, Inc.

  • K033080 — PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER (March 10, 2004)
  • K040014 — PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTROD (February 13, 2004)
  • K032112 — P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (January 26, 2004)
  • K033084 — WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER (December 19, 2003)
  • K032716 — PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERI (November 28, 2003)
  • K030570 — BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE (September 17, 2003)
  • K030381 — PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA (August 27, 2003)
  • K031057 — PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT (July 18, 2003)
  • K031622 — WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS (June 26, 2003)
  • K023793 — 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR (February 11, 2003)

Other clearances for product code BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources