Cleared Traditional

K963365 - MULTI-PURPOSE MEDICAL TUBE HOLDER

K963365 is an FDA 510(k) clearance for MULTI-PURPOSE MEDICAL TUBE HOLDER, manufactured by Byrd Medical Devices, Inc.. The device is a Class 1 General Hospital device with product code KMK cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K963365 · Byrd Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K963365

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

KMK Device Classification - Class 1, General Controls

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.

Regulatory Peers - KMK Device, Intravascular Catheter Securement

All 13
Devices cleared under the same product code (KMK) and FDA review panel - the closest regulatory comparables to K963365.
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
K180994 · Interrad Medical, Inc. · Jul 2019
A P HARNESS
K981860 · Paraworks Enterprise, Ltd. · Jun 1999
CONMED VENI-GARD I.V. DRESSING
K935389 · Conmedcorp · Mar 1994
CENTERMARK SECURING WINGS
K940127 · Menlo Care, Inc. · Feb 1994
DUODERM TRANSPARENT HYDROCOLLOID DRESSING
K925992 · Convatec, A Division of E.R. Squibb & Sons · Oct 1993
IAB ANCHOR
K922103 · Datascope Corp. · Aug 1993