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510(k) K050166

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT by Smiths Medical — Product Code BWC

K050166 is an FDA 510(k) premarket notification submitted by Smiths Medical for the device "PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT". The FDA issued a decision of Substantially Equivalent on May 26, 2005. The device falls under product code BWC (Needle, Emergency Airway), a Class II device regulated under 21 CFR 868.5090. Smiths Medical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2005
Date Received
January 26, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Emergency Airway
Device Class
Class II
Regulation Number
868.5090
Review Panel
AN
Submission Type

Other clearances by Smiths Medical

  • K181660 — Acapella Choice Blue Vibratory PEP Device (October 24, 2019)
  • K041348 — PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR (July 13, 2004)

Other clearances for product code BWC

  • K200190 — ScalpelCric (October 30, 2020)
  • K160200 — Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyr (February 17, 2017)
  • K153761 — Emergency Transtracheal Airway Catheter (September 22, 2016)
  • K130405 — RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (November 6, 2013)
  • K013252 — PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013241 — ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (February 21, 2002)
  • K013916 — MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (December 20, 2001)
  • K010016 — MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (October 9, 2001)
  • K962312 — KEY CHAIN EMERGENCY AIRWAY (June 17, 1997)
  • K952401 — ABELSON CRICOTHYROTOMY CANNULA (July 11, 1995)

FDA data resources