Cleared Traditional

K950613 - KEISEI

K950613 is an FDA 510(k) clearance for KEISEI, manufactured by Keisei (Usa) Co., Ltd.. The device is a Class 1 Anesthesiology device with product code CAE cleared through the Traditional 510(k) pathway after a 369-day FDA review.

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

FDA 510(k) Submission Details - K950613

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 140d · This submission: 369d
Pathway characteristics
Predicate-based equivalence.

CAE Device Classification - Class 1, General Controls

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.

Regulatory Peers - CAE Airway, Oropharyngeal, Anesthesiology

All 22
Devices cleared under the same product code (CAE) and FDA review panel - the closest regulatory comparables to K950613.
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