Cleared Traditional

Vivio System (K183710) - FDA 510(k) Clearance

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

K183710 · Avicena, LLC · Cardiovascular device
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Oct 2019
Decision
277d
Days
Class 2
Risk

K183710 is an FDA 510(k) clearance for the Vivio System. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Avicena, LLC (Altadena, US). The FDA issued a Cleared decision on October 4, 2019 after a review of 277 days - an extended review 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: 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 Avicena, LLC devices

Submission Details

510(k) Number K183710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2018
Decision Date October 04, 2019
Days to Decision 277 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
152d slower than avg
Panel avg: 125d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

West Device Innovations
James West

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQD Stethoscope, Electronic

All 53
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K183710.
HD Steth
K201299 · Hd Medical, Inc. · Jul 2020
Eko CORE
K200776 · Eko Devices, Inc. · Apr 2020
Electronic Stethoscope
K191667 · Hefei Mintti Medical Technology Co., Ltd. China · Dec 2019
eMurmur ID
K181988 · Csd Labs GmbH · Apr 2019
eKuore One electronic interface for stethoscope
K181882 · Chip Ideas Electronics S.L. · Mar 2019
Tyto Stethoscope (OTC)
K181612 · Tyto Care , Ltd. · Dec 2018