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510(k) K861054

DISPOSABLE RESCUE BREATHING DEVICE by B & F Medical Products, Inc. — Product Code CAE

K861054 is an FDA 510(k) premarket notification submitted by B & F Medical Products, Inc. for the device "DISPOSABLE RESCUE BREATHING DEVICE". The FDA issued a decision of Substantially Equivalent on April 9, 1986. The device falls under product code CAE (Airway, Oropharyngeal, Anesthesiology), a Class I device regulated under 21 CFR 868.5110. B & F Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1986
Date Received
March 19, 1986
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 B & F Medical Products, Inc.

  • K942645 — B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG (July 27, 1994)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K913501 — TRACHEOSTOMY MASK (January 13, 1992)
  • K861325 — MAXI-USE O2 DEVICE (September 9, 1986)
  • K853004 — PORTABLE OXYGEN UNIT (August 29, 1985)
  • K843691 — PORTABLE OXYGEN UNIT (November 7, 1984)
  • K823532 — STOCK #64091-PEDIATRIC OXYGEN MASK (January 5, 1983)
  • K811404 — TRAVELAIRE (June 9, 1981)
  • K802644 — EMERG. OXYGEN KIT #65350 & #65399 CASE (December 22, 1980)
  • K802646 — HAND PERCUSSOR CUP #65210 (November 12, 1980)

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