Cleared Traditional

K944686 - FIBEROPTIC LARYNGOSCOPE HANDLE

K944686 is an FDA 510(k) clearance for FIBEROPTIC LARYNGOSCOPE HANDLE, manufactured by Fiberoptic Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K944686 · Fiberoptic Medical Products, Inc. · Anesthesiology device
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Nov 1994
Decision
42d
Days
Class 1
Risk

K944686 is an FDA 510(k) clearance for the FIBEROPTIC LARYNGOSCOPE HANDLE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Fiberoptic Medical Products, Inc. (Allentown, US). The FDA issued a Cleared decision on November 4, 1994 after a review of 42 days - a notably fast clearance cycle.

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: 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 Fiberoptic Medical Products, Inc. devices

FDA 510(k) Submission Details - K944686

510(k) Number K944686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1994
Decision Date November 04, 1994
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
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 29
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K944686.
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
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992