Eko Foundation Analysis Software with Transformers (EFAST)

Q: What is the product code of K251494?

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

FDA 510(k) K251494 · Eko Health, Inc.

Substantially Equivalent

510(k) numberK251494

Submission

Device name: Eko Foundation Analysis Software with Transformers (EFAST)
Applicant: Eko Health, Inc.
Emeryville, CA, US
Received: May 15, 2025
Decision date: August 12, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

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

510(k)	Device	Applicant	Decision
K261494	Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional	Shanghai Hulu Devices Co., Ltd.	07/31/2026SE
K261694	CORE 300 Digital StethoscopeDQD · Traditional	Eko Health, Inc.	07/23/2026SE
K252915	AiSteth®DQD · Traditional	Ai Health Highway India Pvt., Ltd.	05/22/2026SE
K252089	Tyto Stethoscope (G3)DQD · Traditional	Tyto Care , Ltd.	03/12/2026SE
K252076	Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional	Kneevoice, Inc.	02/06/2026SE
K252284	eMurmur Heart AIDQD · Traditional	Csd Labs	12/19/2025SE
K252595	Stethophone ProDQD · Special	Sparrow Acoustics, Inc.	09/12/2025SE
K242971	AccurSound Electronic Stethoscope (AS101)DQD · Traditional	Heroic Faith International , Ltd.	11/25/2024SE
K240901	StethophoneDQD · Traditional	Sparrow Acoustics, Inc.	09/19/2024SE
K233313	Keikku Electronic stethoscopeDQD · Traditional	Lapsi Health Holding B.V.	04/10/2024SE

More from Lapsi Health Holding B.V.

510(k)	Device	Decision
K261694	CORE 300 Digital StethoscopeDQD · Traditional	07/23/2026SE
K233609	CORE 500 Digital StethoscopeDQD · Traditional	03/28/2024SE
K233409	Eko Low Ejection Fraction Tool (ELEFT)QYE · Traditional	03/28/2024SE

Questions and answers

When was Eko Foundation Analysis Software with Transformers (EFAST) cleared by the FDA?

Eko Foundation Analysis Software with Transformers (EFAST) (K251494) received a 510(k) decision of Substantially Equivalent on August 12, 2025, 89 days after the submission was received.

What is the product code of K251494?

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