Cleared Traditional

K230823 - AusculThing ACC (FDA 510(k) Clearance)

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

K230823 · Ausculthing OY · Cardiovascular device
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Jul 2023
Decision
110d
Days
Class 2
Risk

K230823 is an FDA 510(k) clearance for the AusculThing ACC. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Ausculthing OY (Espoo, FI). The FDA issued a Cleared decision on July 12, 2023 after a review of 110 days - within the typical 510(k) review window.

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 Ausculthing OY devices

Submission Details

510(k) Number K230823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2023
Decision Date July 12, 2023
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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 152
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K230823.
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K242971 · Heroic Faith International , Ltd. · Nov 2024