Cleared Traditional

VoqX Electronic Stethoscope (K212709) - FDA 510(k) Clearance

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

K212709 · Sanolla , Ltd. · Cardiovascular device
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Mar 2022
Decision
201d
Days
Class 2
Risk

K212709 is an FDA 510(k) clearance for the VoqX Electronic Stethoscope. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Sanolla , Ltd. (Nesher, IL). The FDA issued a Cleared decision on March 15, 2022 after a review of 201 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 Sanolla , Ltd. devices

Submission Details

510(k) Number K212709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2021
Decision Date March 15, 2022
Days to Decision 201 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
76d slower than avg
Panel avg: 125d · This submission: 201d
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 53
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K212709.
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
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PrevisEA Device
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K210736 · Gv Concepts · Jul 2021