Cleared Traditional

K083321 - CARDIO-VIEW

K083321 is an FDA 510(k) clearance for CARDIO-VIEW, manufactured by Curlview Igt, LLC. The device is a Class 2 Cardiovascular device with product code DXJ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K083321 · Curlview Igt, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
15d
Days
Class 2
Risk

K083321 is an FDA 510(k) clearance for the CARDIO-VIEW. Classified as Display, Cathode-ray Tube, Medical (product code DXJ), Class II - Special Controls.

Submitted by Curlview Igt, LLC (Newton, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2450 - 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 Curlview Igt, LLC devices

FDA 510(k) Submission Details - K083321

510(k) Number K083321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 11, 2008
Decision Date November 26, 2008
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DXJ Device Classification - Class 2, Special Controls

Product Code DXJ Display, Cathode-ray Tube, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2450
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 - DXJ Display, Cathode-ray Tube, Medical

All 61
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K083321.
ZOLL RESCUENET EPCR MODEL RESCUENET EPCR
K103473 · ZOLL Medical Corporation · May 2011
VANTAGE VIEW SYSTEM
K110085 · St Jude Medical · Jan 2011
INTELLIVUE CLINICAL INFORMATION PORTFOLIO
K100272 · Philips Medical Systems · Apr 2010
MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K053356 · Ge Medical Systems Information Technologies · Apr 2006
INFINITY EXPLORER
K013515 · Siemens Medical Solutions USA, Inc. · Jan 2002
GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
K001112 · General Electric Medical Systems Information Techn · Jun 2000