Cleared Traditional

K924551 - ENDO TRACHEA TUBE FIXATION

K924551 is an FDA 510(k) clearance for ENDO TRACHEA TUBE FIXATION, manufactured by M. Imonti and Associates Inc.,. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K924551 · M. Imonti and Associates Inc., · Anesthesiology device
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Dec 1992
Decision
90d
Days
Class 1
Risk

K924551 is an FDA 510(k) clearance for the ENDO TRACHEA TUBE FIXATION. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by M. Imonti and Associates Inc., (San Juan Capistrano, US). The FDA issued a Cleared decision on December 8, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 M. Imonti and Associates Inc., devices

FDA 510(k) Submission Details - K924551

510(k) Number K924551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1992
Decision Date December 08, 1992
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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 - CBH Device, Fixation, Tracheal Tube

All 21
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K924551.
FLEX BLUE
K950318 · King Systems Corp. · Feb 1995
STABILTRACH
K935171 · B&B Medical Technologies, Inc. · Dec 1993
ADHESIVE E.T. TAPE
K925386 · B&B Medical Technologies, Inc. · Apr 1993
E.T. TAPE II
K912884 · B&B Medical Technologies, Inc. · Jul 1991
SALTER LABS MODEL #1015
K903539 · Salter Labs · Dec 1990
BABY E.T. TAPE II
K900912 · B&B Medical Technologies, Inc. · Aug 1990