Cleared Special

K182790 - Cardio-TriTest v6.5

K182790 is the FDA 510(k) clearance for Cardio-TriTest v6.5 by Cardio-Phoenix, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Special 510(k) pathway after a 74-day FDA review.

K182790 · Cardio-Phoenix, Inc. · Cardiovascular device
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Dec 2018
Decision
74d
Days
Class 2
Risk

K182790 is an FDA 510(k) clearance for the Cardio-TriTest v6.5. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cardio-Phoenix, Inc. (Markham, CA). The FDA issued a Cleared decision on December 14, 2018 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardio-Phoenix, Inc. devices

Submission Details

510(k) Number K182790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2018
Decision Date December 14, 2018
Days to Decision 74 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 248
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