Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AiSteth®

K-Number: K252915 · 2026-05-22

ApplicantAi Health Highway India Pvt., Ltd.
Decision Date2026-05-22
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AiSteth® is the device name listed in this FDA 510(k) record. The listed applicant is Ai Health Highway India Pvt., Ltd.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K252915. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AiSteth®?

AiSteth® is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Ai Health Highway India Pvt., Ltd.. The 510(k) number is K252915.

When did AiSteth® receive FDA 510(k) clearance?

AiSteth® received FDA 510(k) clearance on 2026-05-22, under 510(k) number K252915.

Who is the listed applicant for AiSteth®?

The FDA 510(k) record lists Ai Health Highway India Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AiSteth®?

The FDA product code for AiSteth® is DQD.

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd LabsK252595Stethophone ProSparrow Acoustics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑