Cleared Traditional

K192852 - MRI ECG Patient Cable

K192852 is an FDA 510(k) clearance for MRI ECG Patient Cable, manufactured by Ivy Biomedical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LNH cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K192852 · Ivy Biomedical Systems, Inc. · Cardiovascular device
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Mar 2020
Decision
177d
Days
Class 2
Risk

K192852 is an FDA 510(k) clearance for the MRI ECG Patient Cable. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 28, 2020 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 892.1000 - 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 Ivy Biomedical Systems, Inc. devices

FDA 510(k) Submission Details - K192852

510(k) Number K192852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2019
Decision Date March 28, 2020
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 956
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K192852.
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