Cleared Traditional

K812429 - DALE COMBO TRACHEOSTOMY TUBE HOLDER

K812429 is an FDA 510(k) clearance for DALE COMBO TRACHEOSTOMY TUBE HOLDER, manufactured by Dale Medical Products, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EQH cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K812429 · Dale Medical Products, Inc. · Ear, Nose, Throat device
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Sep 1981
Decision
29d
Days
Class 1
Risk

K812429 is an FDA 510(k) clearance for the DALE COMBO TRACHEOSTOMY TUBE HOLDER. Classified as Source, Carrier, Fiberoptic Light (product code EQH), Class I - General Controls.

Submitted by Dale Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4350 - the FDA ear, nose and throat 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 - K812429

510(k) Number K812429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1981
Decision Date September 23, 1981
Days to Decision 29 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 90d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

EQH Device Classification - Class 1, General Controls

Product Code EQH Source, Carrier, Fiberoptic Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4350
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 - EQH Source, Carrier, Fiberoptic Light

All 26
Devices cleared under the same product code (EQH) and FDA review panel - the closest regulatory comparables to K812429.
FIBEROPTIC LIGHT CARRIERS
K822282 · Kelleher Corp. · Aug 1982
ADAPTOR FOR FIBEROPTIC LIGHT SOURCE
K822175 · Kelleher Corp. · Aug 1982
FIBEROPTIC LIGHT CARRIERS
K822192 · Kelleher Corp. · Aug 1982
FIBER OPTIC ADAPTER CAT#60-0898
K802766 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC LIGHT GUIDE CAT#60-0768
K802767 · Aspen Laboratories, Inc. · Dec 1980
FIBER OPTIC ADAPTER #60-0897
K802768 · Aspen Laboratories, Inc. · Dec 1980