DQD · Stethoscope, Electronic · Chrysalis Intelligence

Device class

Class II

Regulation 870.1875

Total clearances

2020-04-06 → 2026-07-31

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.1875

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Chip Ideas Electronics S.L.	4	0	2022-05-26
Sparrow Acoustics, Inc.	4	1	2025-09-12
Eko Devices, Inc.	3	0	2023-05-26
Eko Health, Inc.	3	1	2026-07-23
Csd Labs	2	1	2025-12-19
Entac Medical, Inc.	2	0	2023-05-19
Heroic Faith International , Ltd.	2	0	2024-11-25
Shanghai Hulu Devices Co., Ltd.	2	1	2026-07-31
Heartbuds, LLC	1	0	2023-03-14
Lapsi Health Holding B.V.	1	0	2024-04-10
Nonagon , Ltd.	1	0	2023-04-14
Ai Health Highway India Pvt., Ltd.	1	1	2026-05-22
Sound Land Corp.	1	0	2022-11-03
Stratoscientific	1	0	2022-03-24
M3Dicine Pty , Ltd.	1	0	2020-10-09
Sonavi Labs, Inc.	1	0	2020-09-14
Tyto Care , Ltd.	1	1	2026-03-12
Hd Medical, Inc.	1	0	2020-07-10
Ausculthing OY	1	0	2023-07-12
Homediagnostic, LLC	1	0	2022-10-20
Smartsound Corporation	1	0	2023-08-02
Sanolla , Ltd.	1	0	2022-03-15
Myhomedoc , Ltd.	1	0	2021-03-23
Medaica, Inc.	1	0	2023-01-19
Kneevoice, Inc.	1	1	2026-02-06

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
93000	CPT	—	Medium	Electronic stethoscope may be used in conjunction with cardiac examination/ECG
92004	CPT	—	Low	Device may support comprehensive physical examination

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-31	K261494	Shanghai Hulu Devices Co., Ltd.	Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)
2026-07-23	K261694	Eko Health, Inc.	CORE 300 Digital Stethoscope
2026-05-22	K252915	Ai Health Highway India Pvt., Ltd.	AiSteth®
2026-03-12	K252089	Tyto Care , Ltd.	Tyto Stethoscope (G3)
2026-02-06	K252076	Kneevoice, Inc.	Kneevoice Cartilage Evaluation System (750-3600-001)
2025-12-19	K252284	Csd Labs	eMurmur Heart AI
2025-09-12	K252595	Sparrow Acoustics, Inc.	Stethophone Pro
2025-08-12	K251494	Eko Health, Inc.	Eko Foundation Analysis Software with Transformers (EFAST)
2024-11-25	K242971	Heroic Faith International , Ltd.	AccurSound Electronic Stethoscope (AS101)
2024-09-19	K240901	Sparrow Acoustics, Inc.	Stethophone
2024-04-10	K233313	Lapsi Health Holding B.V.	Keikku Electronic stethoscope
2024-03-28	K233609	Eko Health, Inc.	CORE 500 Digital Stethoscope
2023-10-12	K231551	Sparrow Acoustics, Inc.	Stethophone
2023-08-02	K230613	Smartsound Corporation	SKEEPER
2023-07-12	K230823	Ausculthing OY	AusculThing ACC
2023-05-26	K230111	Eko Devices, Inc.	CORE 500 Digital Stethoscope
2023-05-19	K230769	Entac Medical, Inc.	PrevisEA Device
2023-04-14	K223785	Nonagon , Ltd.	N9+
2023-03-29	K222871	Sparrow Acoustics, Inc.	Stethophone v1
2023-03-23	K221805	Heroic Faith International , Ltd.	AccurSound Electronic Stethoscope AS-101
2023-03-14	K212906	Heartbuds, LLC	HeartBuds Electronic Stethoscope
2023-01-19	K223166	Medaica, Inc.	Medaica M1 Telehealth Stethoscope
2022-11-03	K220466	Sound Land Corp.	ibiomedi Electronic Stethoscope ES-2020
2022-10-20	K220099	Homediagnostic, LLC	eClinic Stethopod
2022-06-29	K213794	Eko Devices, Inc.	Eko Murmur Analysis Software (EMAS)