Cleared Traditional

K020821 - SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117

K020821 is an FDA 510(k) clearance for SCOUT (SINUS CORNARIUS UTILITY TOOL), manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K020821 · Biotronik, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
82d
Days
Class 2
Risk

K020821 is an FDA 510(k) clearance for the SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on June 3, 2002 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Biotronik, Inc. devices

FDA 510(k) Submission Details - K020821

510(k) Number K020821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2002
Decision Date June 03, 2002
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K020821.
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K022357 · Boston Scientific, Target · Oct 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638 · Intra Luminal Therapeutics, Inc. · Jul 2002
ILT TORQUER, MODEL 114TR1
K021243 · Intra Luminal Therapeutics, Inc. · Jul 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
K021323 · Intra Luminal Therapeutics, Inc. · May 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
K021228 · Guidant Corp. · May 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
K021285 · Guidant Corp. · May 2002