Cleared Traditional

K013304 - BD INTROSYTE PRECISION INTRODUCER

K013304 is an FDA 510(k) clearance for BD INTROSYTE PRECISION INTRODUCER, manufactured by Becton Dickinson Infusion Therapy Systems, Inc.. The device is a Class 1 Immunology device with product code DBY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K013304 · Becton Dickinson Infusion Therapy Systems, Inc. · Immunology device
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Jan 2002
Decision
90d
Days
Class 1
Risk

K013304 is an FDA 510(k) clearance for the BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER. Classified as Fab, Rhodamine, Antigen, Antiserum, Control (product code DBY), Class I - General Controls.

Submitted by Becton Dickinson Infusion Therapy Systems, Inc. (Sandy, US). The FDA issued a Cleared decision on January 2, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5520 - the FDA immunology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Becton Dickinson Infusion Therapy Systems, Inc. devices

FDA 510(k) Submission Details - K013304

510(k) Number K013304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2001
Decision Date January 02, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

DBY Device Classification - Class 1, General Controls

Product Code DBY Fab, Rhodamine, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5520
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 - DBY Fab, Rhodamine, Antigen, Antiserum, Control

Devices cleared under the same product code (DBY) and FDA review panel - the closest regulatory comparables to K013304.
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