Cleared Traditional

K950613 - KEISEI (FDA 510(k) Clearance)

Class I Anesthesiology device.

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

K950613 is an FDA 510(k) clearance for the KEISEI. Classified as Airway, Oropharyngeal, Anesthesiology (product code CAE), Class I - General Controls.

Submitted by Keisei (Usa) Co., Ltd. (Torrance, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5110 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Keisei (Usa) Co., Ltd. devices

Submission Details

510(k) Number K950613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 139d · This submission: 369d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAE Airway, Oropharyngeal, Anesthesiology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.