Cleared Traditional

K181612 - Tyto Stethoscope (OTC) (FDA 510(k) Clearance)

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

K181612 · Tyto Care , Ltd. · Cardiovascular device
Dec 2018
Decision
181d
Days
Class 2
Risk

K181612 is an FDA 510(k) clearance for the Tyto Stethoscope (OTC). Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Cleared decision on December 17, 2018 after a review of 181 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.

Submission Details

510(k) Number K181612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2018
Decision Date December 17, 2018
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 140d · This submission: 181d
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 K181612.
Tyto Stethoscope (G3)
K252089 · Tyto Care , Ltd. · Mar 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · Kneevoice, Inc. · Feb 2026
eMurmur Heart AI
K252284 · Csd Labs · Dec 2025
Stethophone Pro
K252595 · Sparrow Acoustics, Inc. · Sep 2025
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K251494 · Eko Health, Inc. · Aug 2025