Cleared Traditional

K000366 - FIXATION STYLETS, MODELS 335-287 AND 335-288

K000366 is an FDA 510(k) clearance for FIXATION STYLETS, manufactured by Accufix Research Institute. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K000366 · Accufix Research Institute · Cardiovascular device
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Apr 2000
Decision
70d
Days
Class 2
Risk

K000366 is an FDA 510(k) clearance for the FIXATION STYLETS, MODELS 335-287 AND 335-288. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Accufix Research Institute (Englewood, US). The FDA issued a Cleared decision on April 14, 2000 after a review of 70 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 Accufix Research Institute devices

FDA 510(k) Submission Details - K000366

510(k) Number K000366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date April 14, 2000
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
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 21
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K000366.
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular · Jun 2000
TFX MEDICAL STYLET CATHETER
K992664 · Tfx Medical Group · Apr 2000
ENSTYLET MODELS EC0010, EC0020
K993376 · Endocardial Solutions, Inc. · Jan 2000
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · Guidant Corp. · Nov 1999