Cleared Traditional

Steth IO Spot (K220196) - FDA 510(k) Clearance

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

K220196 · Stratoscientific · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
59d
Days
Class 2
Risk

K220196 is an FDA 510(k) clearance for the Steth IO Spot. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Stratoscientific (Bothell, US). The FDA issued a Cleared decision on March 24, 2022 after a review of 59 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.

View all Stratoscientific devices

Submission Details

510(k) Number K220196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2022
Decision Date March 24, 2022
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 K220196.
eMurmur Heart AI
K220766 · Csd Labs GmbH · May 2022
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
K211779 · Chip Ideas Electronics S.L. · May 2022
Smart Wireless Stethoscope
K220470 · Shanghai Hulu Devices Co., Ltd. · May 2022
VoqX Electronic Stethoscope
K212709 · Sanolla , Ltd. · Mar 2022
eKuore Pro 4T - REF EP0098
K212013 · Chip Ideas Electronics S.L. · Nov 2021
PrevisEA Device
K211068 · Entac Medical, Inc. · Aug 2021