Cleared Traditional

K954438 - SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE

K954438 is an FDA 510(k) clearance for SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE, manufactured by Rms Div.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K954438 · Rms Div. · Anesthesiology device
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Dec 1995
Decision
95d
Days
Class 1
Risk

K954438 is an FDA 510(k) clearance for the SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Rms Div. (Palm Harbor, US). The FDA issued a Cleared decision on December 29, 1995 after a review of 95 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 Rms Div. devices

FDA 510(k) Submission Details - K954438

510(k) Number K954438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date December 29, 1995
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
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 21
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K954438.
BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
K961832 · Blue Ridge Medical, Inc. · Sep 1996
LARYNGOSCOPE COVER
K945301 · Sotiria Mourkidou, M.D. · May 1996
ILLUMINATOR
K954787 · Hospitak, Inc. · Jan 1996
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