Cleared Abbreviated

K151781 - Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K151781 · Ivy Biomedical Systems, Inc. · Cardiovascular device
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May 2016
Decision
331d
Days
Class 2
Risk

K151781 is an FDA 510(k) clearance for the Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on May 27, 2016 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ivy Biomedical Systems, Inc. devices

Submission Details

510(k) Number K151781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date May 27, 2016
Days to Decision 331 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 125d · This submission: 331d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

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