Cleared Traditional

K945473 - V-CATH BREAKAWAY NEEDLE INTRODUCER

K945473 is an FDA 510(k) clearance for V-CATH BREAKAWAY NEEDLE INTRODUCER, manufactured by Hdc Corp.. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K945473 · Hdc Corp. · General Hospital
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Jan 1995
Decision
73d
Days
Class 2
Risk

K945473 is an FDA 510(k) clearance for the V-CATH BREAKAWAY NEEDLE INTRODUCER. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Hdc Corp. (San Jose, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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 Hdc Corp. devices

FDA 510(k) Submission Details - K945473

510(k) Number K945473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1994
Decision Date January 20, 1995
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KZH Introducer, Syringe Needle

All 8
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K945473.
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · Medtronic Minimed · Mar 1997
V-CATH PERCUTANEOUS INTRODUCER KIT
K951384 · Hdc Corp. · Jun 1995
MONOJECT INJECTOMATIC
K832683 · Sherwood Medical Co. · Sep 1983