Cleared Traditional

LARYNGOSTAT LARYNGOSCOPE HANDLE (K895954) - FDA 510(k) Clearance

Class I Anesthesiology device.

K895954 · Michigan Instruments, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
19d
Days
Class 1
Risk

K895954 is an FDA 510(k) clearance for the LARYNGOSTAT LARYNGOSCOPE HANDLE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Michigan Instruments, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on October 30, 1989 after a review of 19 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 Michigan Instruments, Inc. devices

Submission Details

510(k) Number K895954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date October 30, 1989
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
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 K895954.
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
FIBER OPTIC LARYNGOSCOPES W/BATTERY
K830047 · Welch Allyn, Inc. · Jan 1983
OROTRACHEAL INTUBATION ENDOSCOPE
K801452 · Olympus Corp. · Jul 1980