Cleared Traditional

KEISEI

K950613 · Keisei (Usa) Co., Ltd. · Anesthesiology
Feb 1996
Decision
369d
Days
Class 1
Risk

About This 510(k) Submission

K950613 is an FDA 510(k) clearance for the KEISEI, a Airway, Oropharyngeal, Anesthesiology (Class I — General Controls, product code CAE), submitted by Keisei (Usa) Co., Ltd. (Torrance, US). The FDA issued a Cleared decision on February 14, 1996, 369 days after receiving the submission on February 10, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5110.

Submission Details

510(k) Number K950613 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1995
Decision Date February 14, 1996
Days to Decision 369 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAE — Airway, Oropharyngeal, Anesthesiology
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5110

Similar Devices — CAE Airway, Oropharyngeal, Anesthesiology

All 56
LMA FAMILY OF AIRWAYS
K130304 · The Laryngeal Mask Co., Ltd. · May 2014
KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
K033189 · King Systems Corp. · May 2004
KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
K033186 · King Systems Corp. · Apr 2004
KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
K021634 · King Systems Corp. · Jan 2003
CUFFED OROPHARYNGEAL AIRWAY (COPA)
K955721 · Mallinckrodt Medical · Mar 1997
RUSCH OPTOSAFE
K960240 · Rusch Intl. · Apr 1996