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510(k) K130304

LMA FAMILY OF AIRWAYS by The Laryngeal Mask Co., Ltd. — Product Code CAE

K130304 is an FDA 510(k) premarket notification submitted by The Laryngeal Mask Co., Ltd. for the device "LMA FAMILY OF AIRWAYS". The FDA issued a decision of Substantially Equivalent on May 30, 2014. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. The Laryngeal Mask Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2014
Date Received
February 7, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Airway, Oropharyngeal, Anesthesiology
Device Class
Class I
Regulation Number
868.5110
Review Panel
AN
Submission Type

Other clearances by The Laryngeal Mask Co., Ltd.

  • K062475 — LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM (May 9, 2007)
  • K051993 — LMA FASTRACH ETT SINGLE USE (December 13, 2005)
  • K991580 — ILM ENDOTRACHEAL TUBE (February 4, 2000)

Other clearances for product code CAE

  • K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 30 (May 4, 2004)
  • K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (April 14, 2004)
  • K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (January 9, 2003)
  • K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA) (March 28, 1997)
  • K960240 — RUSCH OPTOSAFE (April 19, 1996)
  • K950613 — KEISEI (February 14, 1996)
  • K953400 — GUEDEL AIRWAY (October 24, 1995)
  • K933760 — STB GUEDEL AIRWAY (March 23, 1994)
  • K936134 — BERMAN AIRWAY (January 28, 1994)
  • K922748 — GUEDEL AIRWAY (July 10, 1992)

FDA data resources