Cleared Traditional

K860583 - DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315

K860583 is an FDA 510(k) clearance for DALE HEAD BAND ANESTHESIA CIRCUIT TUBE ..., manufactured by Dale Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code JAY cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K860583 · Dale Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Feb 1986
Decision
3d
Days
Class 1
Risk

K860583 is an FDA 510(k) clearance for the DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315. Classified as Support, Breathing Tube (product code JAY), Class I - General Controls.

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on February 21, 1986 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5280 - 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 - K860583

510(k) Number K860583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1986
Decision Date February 21, 1986
Days to Decision 3 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 140d · This submission: 3d
Pathway characteristics
Predicate-based equivalence.

JAY Device Classification - Class 1, General Controls

Product Code JAY Support, Breathing Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5280
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 - JAY Support, Breathing Tube

All 8
Devices cleared under the same product code (JAY) and FDA review panel - the closest regulatory comparables to K860583.
BLOCK, BITE, INTUBATION
K873491 · B&B Medical Technologies, Inc. · Oct 1987
COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
K850309 · Ackrad Laboratories · Feb 1985
COMFIT
K834089 · Ackrad Laboratories · Dec 1983
ENDOTRACHEAL TUBE HOLDER
K802675 · Respiratory Support Products, Inc. · Nov 1980
ADJUSTABLE TUBE TREE FOR ANESTH. HOSES
K792148 · Medical Innovations Corp. · Nov 1979
TUBE-STRAP
K791781 · Olympic Medical Corp. · Sep 1979