Cleared Traditional

K833866 - ACE/KYLE SELF TAPPING CANNULATED TITA (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K833866 · Buckman Co., Inc. · Ear, Nose, Throat device
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Dec 1983
Decision
50d
Days
Class 1
Risk

K833866 is an FDA 510(k) clearance for the ACE/KYLE SELF TAPPING CANNULATED TITA. Classified as Pump, Nebulizer, Electrically Powered (product code JPW), Class I - General Controls.

Submitted by Buckman Co., Inc. (Walker, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5220 - 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K833866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1983
Decision Date December 27, 1983
Days to Decision 50 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
39d faster than avg
Panel avg: 89d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JPW Pump, Nebulizer, Electrically Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5220
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.