Cleared Traditional

CARDIO-VIEW (K083321) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 77
Devices cleared under the same product code (DXJ) and FDA review panel - the closest regulatory comparables to K083321.
ESSENZ Patient Monitor
K212003 · Livanova Deutschland, GmbH · Nov 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208 · Philips Medizin Systeme Boeblingen GmbH · Sep 2021
Essence 55SP Large Monitor System
K201162 · Shenyang Torch-Bigtide Digital Technology Co., Ltd. · Aug 2020
Vios Central Station Monitor Software, Vios Central Server Software
K173107 · Vios Medical, Inc. · Jul 2018
Philips IntelliVue GuardianSoftware
K180534 · Philips Medizin Systeme Boeblingen GmbH · Jul 2018
Nexxis OR
K173381 · Barco N.V. · Feb 2018