Cleared Traditional

K964399 - DALE ENDOTRACHEAL TUBE HOLDER 270/280

K964399 is an FDA 510(k) clearance for DALE ENDOTRACHEAL TUBE HOLDER 270/280, manufactured by Dale Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K964399 · Dale Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
85d
Days
Class 1
Risk

K964399 is an FDA 510(k) clearance for the DALE ENDOTRACHEAL TUBE HOLDER 270/280. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on January 28, 1997 after a review of 85 days - a notably fast clearance cycle.

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: 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 Dale Medical Products, Inc. devices

FDA 510(k) Submission Details - K964399

510(k) Number K964399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date January 28, 1997
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
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 20
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K964399.
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · Applied Medical Technology, Inc. · Sep 2014
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