Cleared Traditional

K062977 - CRITIVIEW

K062977 is the FDA 510(k) clearance for CRITIVIEW by Critisense , Ltd.. It is a Class 2 Cardiovascular device (product code DPW) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K062977 · Critisense , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
152d
Days
Class 2
Risk

K062977 is an FDA 510(k) clearance for the CRITIVIEW, MODEL CRV3. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Critisense , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on February 28, 2007 after a review of 152 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Critisense , Ltd. devices

Submission Details

510(k) Number K062977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2006
Decision Date February 28, 2007
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 125d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 34
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