Cleared Traditional

K954787 - ILLUMINATOR

K954787 is an FDA 510(k) clearance for ILLUMINATOR, manufactured by Hospitak, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K954787

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 140d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

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.

Regulatory Peers - CCW Laryngoscope, Rigid

All 14
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K954787.
APA Oxy Blade
K191602 · Venner Medical (Singapore) Pte, Ltd. · Aug 2019
AUGUSTINE INTUBATION GUIDE
K954446 · Augustine Medical, Inc. · Dec 1995
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
K951804 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
MCINTOSH, MILLER, FOREGGER BABY
K945425 · Rudolf Riester GmbH & Co. KG · Mar 1995
AUGUSTINE FIBEROPTIC LARYNGOSCOPE
K915161 · Augustine Medical, Inc. · May 1992
AUGUSTINE GUIDE KIT
K921166 · Augustine Medical, Inc. · Apr 1992