Cleared Traditional

K844776 - EFFNER-SALING LARYNGOSCOPE FOR NEW-BORN

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

K844776 · Medical Instruments and Lamps · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Medical Instruments and Lamps devices

Submission Details

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.

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.

Regulatory Peers - CCW Laryngoscope, Rigid

Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K844776.
APA Oxy Blade
K191602 · Venner Medical (Singapore) Pte, Ltd. · Aug 2019
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
K951804 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992
FIBER OPTIC LARYNGOSCOPES W/BATTERY
K830047 · Welch Allyn, Inc. · Jan 1983
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · Olympus Corp. · Jul 1980