Cleared Traditional

K963365 - MULTI-PURPOSE MEDICAL TUBE HOLDER (FDA 510(k) Clearance)

Class I General Hospital device.

K963365 · Byrd Medical Devices, Inc. · General Hospital
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Oct 1996
Decision
45d
Days
Class 1
Risk

K963365 is an FDA 510(k) clearance for the MULTI-PURPOSE MEDICAL TUBE HOLDER. Classified as Device, Intravascular Catheter Securement (product code KMK), Class I - General Controls.

Submitted by Byrd Medical Devices, Inc. (Knoxville, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5210 - the FDA general hospital 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 Byrd Medical Devices, Inc. devices

Submission Details

510(k) Number K963365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1996
Decision Date October 11, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 128d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMK Device, Intravascular Catheter Securement
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5210
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.