Cleared Traditional

K090163 - STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078

K090163 is an FDA 510(k) clearance for STYLET, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K090163 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
69d
Days
Class 2
Risk

K090163 is an FDA 510(k) clearance for the STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by St Jude Medical (Sylmar, US). The FDA issued a Cleared decision on April 1, 2009 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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: 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 St Jude Medical devices

FDA 510(k) Submission Details - K090163

510(k) Number K090163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2009
Decision Date April 01, 2009
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
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: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 22
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K090163.
GaltTWS
K182660 · Galt Medical Corp. · May 2019
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated · Oct 2017
LLD EZ
K142116 · Spectranetics, Inc. · Aug 2014
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
K080924 · St. Jude Medical, Cardiac Rhythm Management Divisi · Apr 2008
ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
K072864 · St. Jude Medical, Cardiac Rhythm Management Divisi · Mar 2008
ACUITY STEERABLE STYLET ACCESSORY
K053019 · Guidant Corporation · Mar 2006