Cleared Traditional

K200862 - Feelix Stethoscope

K200862 is the FDA 510(k) clearance for Feelix Stethoscope by Sonavi Labs, Inc.. It is a Class 2 Cardiovascular device (product code DQD) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K200862 · Sonavi Labs, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2020
Decision
166d
Days
Class 2
Risk

K200862 is an FDA 510(k) clearance for the Feelix Stethoscope. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Sonavi Labs, Inc. (Baltimore, US). The FDA issued a Cleared decision on September 14, 2020 after a review of 166 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 Sonavi Labs, Inc. devices

Submission Details

510(k) Number K200862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2020
Decision Date September 14, 2020
Days to Decision 166 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
41d slower than avg
Panel avg: 125d · This submission: 166d
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 Peers - DQD Stethoscope, Electronic

All 58
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K200862.
eKuore One Wireless Electronic Interface for stethoscope
K201742 · Chip Ideas Electronics S.L. · Nov 2020
eKuore Pro Series
K203007 · Chip Ideas Electronics S.L. · Oct 2020
Stethee Pro 1, Stethee Pro Software System
K193631 · M3Dicine Pty , Ltd. · Oct 2020
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