Smart Wireless Stethoscope

FDA 510(k) K220470 · Shanghai Hulu Devices Co., Ltd.

Substantially Equivalent

510(k) numberK220470

Submission

Device name
Smart Wireless Stethoscope
Applicant
Shanghai Hulu Devices Co., Ltd.
Shanghai, CN
Received
February 18, 2022
Decision date
May 23, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
DQD – Stethoscope, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1875
Specialty
Cardiovascular

Other 510(k)s with product code DQD

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K252915AiSteth®DQD · Traditional Ai Health Highway India Pvt., Ltd.05/22/2026SE
K252089Tyto Stethoscope (G3)DQD · Traditional Tyto Care , Ltd.03/12/2026SE
K252076Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional Kneevoice, Inc.02/06/2026SE
K252284eMurmur Heart AIDQD · Traditional Csd Labs12/19/2025SE
K252595Stethophone ProDQD · Special Sparrow Acoustics, Inc.09/12/2025SE
K251494Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional Eko Health, Inc.08/12/2025SE
K242971AccurSound Electronic Stethoscope (AS101)DQD · Traditional Heroic Faith International , Ltd.11/25/2024SE
K240901StethophoneDQD · Traditional Sparrow Acoustics, Inc.09/19/2024SE

More from Sparrow Acoustics, Inc.

510(k)DeviceDecision
K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional 07/31/2026SE
K180335Accutension Smartphone Auscultatory BloodDXQ · Traditional 03/08/2018SE

Questions and answers

When was Smart Wireless Stethoscope cleared by the FDA?

Smart Wireless Stethoscope (K220470) received a 510(k) decision of Substantially Equivalent on May 23, 2022, 94 days after the submission was received.

What is the product code of K220470?

The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.