Cleared Traditional

K191692 - KardioScreen

K191692 is the FDA 510(k) clearance for KardioScreen by Imedrix Inc. (Formerly Piitech Inc.). It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K191692 · Imedrix Inc. (Formerly Piitech Inc.) · Cardiovascular device
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Jan 2020
Decision
199d
Days
Class 2
Risk

K191692 is an FDA 510(k) clearance for the KardioScreen. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Imedrix Inc. (Formerly Piitech Inc.) (Milpitas, US). The FDA issued a Cleared decision on January 10, 2020 after a review of 199 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Imedrix Inc. (Formerly Piitech Inc.) devices

Submission Details

510(k) Number K191692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2019
Decision Date January 10, 2020
Days to Decision 199 days
Submission Type Traditional
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
74d slower than avg
Panel avg: 125d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K191692.
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K182093 · Zoll Manufacturing Corporation · Jan 2019