Cleared Traditional

K951491 - DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS

K951491 is an FDA 510(k) clearance for DALE TRACHEOSTOMY TUBE HOLDER WITH TRAC..., 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 24-day FDA review.

K951491 · Dale Medical Products, Inc. · Anesthesiology device
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Apr 1995
Decision
24d
Days
Class 1
Risk

K951491 is an FDA 510(k) clearance for the DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS. 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 April 24, 1995 after a review of 24 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 - K951491

510(k) Number K951491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1995
Decision Date April 24, 1995
Days to Decision 24 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
116d faster than avg
Panel avg: 140d · This submission: 24d
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 K951491.
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STABILTRACH
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K925386 · B&B Medical Technologies, Inc. · Apr 1993
E.T. TAPE II
K912884 · B&B Medical Technologies, Inc. · Jul 1991