Cleared Traditional

K230613 - SKEEPER

K230613 is an FDA 510(k) clearance for SKEEPER, manufactured by Smartsound Corporation. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K230613 · Smartsound Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
149d
Days
Class 2
Risk

K230613 is an FDA 510(k) clearance for the SKEEPER. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Smartsound Corporation (Seoul, KR). The FDA issued a Cleared decision on August 2, 2023 after a review of 149 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 Smartsound Corporation devices

FDA 510(k) Submission Details - K230613

510(k) Number K230613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2023
Decision Date August 02, 2023
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

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 K230613.
Keikku Electronic stethoscope
K233313 · Lapsi Health Holding B.V. · Apr 2024
CORE 500 Digital Stethoscope
K233609 · Eko Health, Inc. · Mar 2024
Stethophone
K231551 · Sparrow Acoustics, Inc. · Oct 2023
AusculThing ACC
K230823 · Ausculthing OY · Jul 2023
CORE 500 Digital Stethoscope
K230111 · Eko Devices, Inc. · May 2023
PrevisEA Device
K230769 · Entac Medical, Inc. · May 2023