Cleared Traditional

K950318 - FLEX BLUE

K950318 is an FDA 510(k) clearance for FLEX BLUE, manufactured by King Systems Corp.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K950318 · King Systems Corp. · Anesthesiology device
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Feb 1995
Decision
18d
Days
Class 1
Risk

K950318 is an FDA 510(k) clearance for the FLEX BLUE. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all King Systems Corp. devices

FDA 510(k) Submission Details - K950318

510(k) Number K950318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1995
Decision Date February 13, 1995
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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 - CBH Device, Fixation, Tracheal Tube

All 19
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