Cleared Traditional

K954787 - ILLUMINATOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K954787 · Hospitak, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
105d
Days
Class 1
Risk

K954787 is an FDA 510(k) clearance for the ILLUMINATOR. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Hospitak, Inc. (Farmingdale, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - 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. Standard predicate reliance. 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 Hospitak, Inc. devices

Submission Details

510(k) Number K954787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1995
Decision Date January 31, 1996
Days to Decision 105 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 139d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
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.