Cleared Traditional

K844776 - EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN

K844776 is an FDA 510(k) clearance for EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN, manufactured by Medical Instruments and Lamps. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K844776 · Medical Instruments and Lamps · Anesthesiology device
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Oct 1985
Decision
295d
Days
Class 1
Risk

K844776 is an FDA 510(k) clearance for the EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Medical Instruments and Lamps (Port Washington, US). The FDA issued a Cleared decision on October 1, 1985 after a review of 295 days - an extended review 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: 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.

FDA 510(k) Submission Details - K844776

510(k) Number K844776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1984
Decision Date October 01, 1985
Days to Decision 295 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 140d · This submission: 295d
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 44
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K844776.
LARYNGOSTAT LARYNGOSCOPE HANDLE
K895954 · Michigan Instruments, Inc. · Oct 1989
LASER LARYNGOSCOPE DEDO ARTICULA. & FEDER DEDO EX
K882930 · Pilling Co. · Aug 1988
AUGUSTINE INTUBATION GUIDE(TM)
K882659 · Augustine Medical, Inc. · Jul 1988
LARYNGOSCOPE BLADES/HANDLES & LAMPS
K833055 · Medovations, Inc. · Nov 1983
FIBER OPTIC LARYNGOSCOPES W/BATTERY
K830047 · Welch Allyn, Inc. · Jan 1983
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · Olympus Corp. · Jul 1980
K844776 · EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN
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