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510(k) K810651

ORAL AIRWAYS by First Industries, Inc. — Product Code CAE

K810651 is an FDA 510(k) premarket notification submitted by First Industries, Inc. for the device "ORAL AIRWAYS". The FDA issued a decision of Substantially Equivalent on March 31, 1981. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. First Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1981
Date Received
March 10, 1981
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 First Industries, Inc.

  • K810652 — TUBING CONNECTORS (March 31, 1981)
  • K810654 — STOPPERLESS HOT/COLD RUBBER WATER BOTTLE (March 27, 1981)
  • K810653 — VINYL ICE BAG (March 27, 1981)
  • K810649 — INVALID CUSHION (March 26, 1981)
  • K810650 — CRUTCH TIPS & GRIPS (March 26, 1981)

Other clearances for product code CAE

  • K130304 — LMA FAMILY OF AIRWAYS (May 30, 2014)
  • 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)

FDA data resources