Cleared Traditional

K071231 - EDAC QUANTIFIER

K071231 is an FDA 510(k) clearance for EDAC QUANTIFIER, manufactured by Luna Innovations, Inc.. The device is a Class 2 Cardiovascular device with product code KRL cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K071231 · Luna Innovations, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
14d
Days
Class 2
Risk

K071231 is an FDA 510(k) clearance for the EDAC QUANTIFIER. Classified as Detector, Bubble, Cardiopulmonary Bypass (product code KRL), Class II - Special Controls.

Submitted by Luna Innovations, Inc. (Blacksburg, US). The FDA issued a Cleared decision on May 17, 2007 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4205 - 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 Luna Innovations, Inc. devices

FDA 510(k) Submission Details - K071231

510(k) Number K071231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2007
Decision Date May 17, 2007
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KRL Device Classification - Class 2, Special Controls

Product Code KRL Detector, Bubble, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4205
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 - KRL Detector, Bubble, Cardiopulmonary Bypass

All 12
Devices cleared under the same product code (KRL) and FDA review panel - the closest regulatory comparables to K071231.
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SARNS AIR DETECTION SYSTEM
K935977 · 3M Health Care, Sarns · Feb 1994
STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
K925661 · Sorin Biomedica, Fiat, USA, Inc. · May 1993