510(k) · Cleared
ClearedAiSteth®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ai Health Highway India Pvt., Ltd. · DQD Stethoscope, Electronic
Cleared on May 22, 2026 as substantially equivalent to K151319 (Eko Devices, Inc., 2015) after a 252-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- May 22, 2026
- Review
- 252 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151319 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backK151319 Eko Electronic Stethoscope SystemEko Devices, Inc. · 2015
- This deviceK252915 AiSteth®Ai Health Highway India Pvt., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151319 | Eko Electronic Stethoscope System | Eko Devices, Inc. | 2015 | — |
| 0 (this device) | K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQD device
- #1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151319 | Eko Electronic Stethoscope SystemSummary page 6…Eko Devices, Inc, Oregon, has been identified as the predicate for AiSteth® to support the substantial equivalence comparison. 510(k) K151319 Trade/Proprietary Name Eko Electronic Stethoscope System Regulation Name Stethoscope Regulation Number… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K151319.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQD
No recall names DQD since 2007.
Adverse event reports per year · DQD
1in 2024
MAUDE reports naming product code DQD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
The AiSteth® Platform (AiSteth® Device + Mobile applications on Android & iOS) is intended to be used as part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. AiSteth® is intended for use on pediatric and adult patients. It can record, store, amplify, filter and share sounds on the accompanying mobile applications for storage and sharing. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252915: AiSteth®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252915
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026