Cleared Traditional

K903199 - HOLLOW LUMEN NEEDLE

K903199 is the FDA 510(k) clearance for HOLLOW LUMEN NEEDLE by Medex, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K903199 · Medex, Inc. · Cardiovascular device
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Dec 1990
Decision
150d
Days
Class 2
Risk

K903199 is an FDA 510(k) clearance for the HOLLOW LUMEN NEEDLE, PART NUMBER: MX920. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Medex, Inc. (Dublin, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medex, Inc. devices

Submission Details

510(k) Number K903199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1990
Decision Date December 17, 1990
Days to Decision 150 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K903199.
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K905727 · C.R. Bard, Inc. · Feb 1991
MEWISSEN CATHETER
K904788 · Boston Scientific Corp · Dec 1990
ARTERIAL BLOOD SAMPLING KIT
K902771 · Medex, Inc. · Nov 1990
SOFTOUCH GUIDING CATHETER
K902953 · Mallinckrodt Medical · Sep 1990