Cleared Traditional

K121860 - ESA615

K121860 is an FDA 510(k) clearance for ESA615, manufactured by Fluke Biomedical. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K121860 · Fluke Biomedical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2013
Decision
213d
Days
Class 2
Risk

K121860 is an FDA 510(k) clearance for the ESA615. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Fluke Biomedical (Cleveland, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 213 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Fluke Biomedical devices

FDA 510(k) Submission Details - K121860

510(k) Number K121860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2012
Decision Date January 25, 2013
Days to Decision 213 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
88d slower than avg
Panel avg: 125d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

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)

All 200
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K121860.
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