Cleared Traditional

K882018 - MEDACORD PVL

K882018 is an FDA 510(k) clearance for MEDACORD PVL, manufactured by Medasonics, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K882018 · Medasonics, Inc. · Radiology device
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Sep 1988
Decision
131d
Days
Class 2
Risk

K882018 is an FDA 510(k) clearance for the MEDACORD PVL, PERSONAL VASCULAR LABORATORY. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Medasonics, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 21, 1988 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medasonics, Inc. devices

FDA 510(k) Submission Details - K882018

510(k) Number K882018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1988
Decision Date September 21, 1988
Days to Decision 131 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 107d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 Radiology devices follow this clearance model.

Regulatory Peers - JAF Monitor, Ultrasonic, Nonfetal

All 12
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K882018.
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