Cleared Traditional

K182196 - Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182196 · Imediplus, Inc. · Cardiovascular device
Sep 2018
Decision
28d
Days
Class 2
Risk

K182196 is an FDA 510(k) clearance for the Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope.... Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Imediplus, Inc. (Chupei City, TW). The FDA issued a Cleared decision on September 11, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

Submission Details

510(k) Number K182196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2018
Decision Date September 11, 2018
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 - DQD Stethoscope, Electronic

Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K182196.
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