Cleared Traditional

K901164 - NEUSTEIN LARYNGOSCOPE

K901164 is an FDA 510(k) clearance for NEUSTEIN LARYNGOSCOPE, manufactured by Neutech Corp.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K901164 · Neutech Corp. · Anesthesiology device
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Oct 1990
Decision
211d
Days
Class 1
Risk

K901164 is an FDA 510(k) clearance for the NEUSTEIN LARYNGOSCOPE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Neutech Corp. (Englewood, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 211 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 - K901164

510(k) Number K901164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date October 09, 1990
Days to Decision 211 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 140d · This submission: 211d
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 42
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K901164.
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992
PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM.
K915804 · Propper Mfg. Co., Inc. · Mar 1992
AUGUSTINE GUIDE KIT WITH GAUZE SPONGE
K914168 · Augustine Medical, Inc. · Oct 1991
BAUMAN RIGID LARYNGOSCOPE
K901680 · Palex Intl. SA · Jul 1990
MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)
K901489 · Eastmed Enterprises, Inc. · Apr 1990
LARYNGOSTAT LARYNGOSCOPE HANDLE
K895954 · Michigan Instruments, Inc. · Oct 1989
K901164 · NEUSTEIN LARYNGOSCOPE
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