Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DQD — Predicate Candidate Screening
156 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
259 days90th percentile
156clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethos | Shanghai Hulu Devices Co., Ltd. | 2026-07-31 | 86 | 0 |
| K261694 | CORE 300 Digital Stethoscope | Eko Health, Inc. | 2026-07-23 | 62 | 0 |
| K252915 | AiSteth® | Ai Health Highway India Pvt., Ltd. | 2026-05-22 | 252 | 0 |
| K252089 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | 2026-03-12 | 253 | 0 |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | 2026-02-06 | 219 | 0 |
| K252284 | eMurmur Heart AI | Csd Labs | 2025-12-19 | 150 | 0 |
| K252595 | Stethophone Pro | Sparrow Acoustics, Inc. | 2025-09-12 | 28 | 0 |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Eko Health, Inc. | 2025-08-12 | 89 | 0 |
| K242971 | AccurSound Electronic Stethoscope (AS101) | Heroic Faith International , Ltd. | 2024-11-25 | 60 | 0 |
| K240901 | Stethophone | Sparrow Acoustics, Inc. | 2024-09-19 | 170 | 0 |
| K233313 | Keikku Electronic stethoscope | Lapsi Health Holding B.V. | 2024-04-10 | 194 | 0 |
| K233609 | CORE 500 Digital Stethoscope | Eko Health, Inc. | 2024-03-28 | 136 | 0 |
| K231551 | Stethophone | Sparrow Acoustics, Inc. | 2023-10-12 | 135 | 0 |
| K230613 | SKEEPER | Smartsound Corporation | 2023-08-02 | 149 | 0 |
| K230823 | AusculThing ACC | Ausculthing OY | 2023-07-12 | 110 | 0 |
| K230111 | CORE 500 Digital Stethoscope | Eko Devices, Inc. | 2023-05-26 | 129 | 0 |
| K230769 | PrevisEA Device | Entac Medical, Inc. | 2023-05-19 | 60 | 0 |
| K223785 | N9+ | Nonagon , Ltd. | 2023-04-14 | 119 | 0 |
| K222871 | Stethophone v1 | Sparrow Acoustics, Inc. | 2023-03-29 | 188 | 0 |
| K221805 | AccurSound Electronic Stethoscope AS-101 | Heroic Faith International , Ltd. | 2023-03-23 | 274 | 0 |
| K212906 | HeartBuds Electronic Stethoscope | Heartbuds, LLC | 2023-03-14 | 547 | 0 |
| K223166 | Medaica M1 Telehealth Stethoscope | Medaica, Inc. | 2023-01-19 | 104 | 0 |
| K220466 | ibiomedi Electronic Stethoscope ES-2020 | Sound Land Corp. | 2022-11-03 | 259 | 0 |
| K220099 | eClinic Stethopod | Homediagnostic, LLC | 2022-10-20 | 281 | 0 |
| K213794 | Eko Murmur Analysis Software (EMAS) | Eko Devices, Inc. | 2022-06-29 | 205 | 0 |
| K220766 | eMurmur Heart AI | Csd Labs GmbH | 2022-05-31 | 76 | 0 |
| K211779 | ES001 Digital stethoscope for general-purpose auscultation, | Chip Ideas Electronics S.L. | 2022-05-26 | 351 | 0 |
| K220470 | Smart Wireless Stethoscope | Shanghai Hulu Devices Co., Ltd. | 2022-05-23 | 94 | 0 |
| K220196 | Steth IO Spot | Stratoscientific | 2022-03-24 | 59 | 0 |
| K212709 | VoqX Electronic Stethoscope | Sanolla , Ltd. | 2022-03-15 | 201 | 0 |
| K212013 | eKuore Pro 4T - REF EP0098 | Chip Ideas Electronics S.L. | 2021-11-10 | 135 | 0 |
| K211068 | PrevisEA Device | Entac Medical, Inc. | 2021-08-04 | 114 | 0 |
| K210736 | doctorgram Stethoscope DES-I | Gv Concepts | 2021-07-27 | 138 | 0 |
| K202483 | MyHomeDoc | Myhomedoc , Ltd. | 2021-03-23 | 207 | 0 |
| K201742 | eKuore One Wireless Electronic Interface for stethoscope | Chip Ideas Electronics S.L. | 2020-11-24 | 152 | 0 |
| K203007 | eKuore Pro Series | Chip Ideas Electronics S.L. | 2020-10-30 | 29 | 0 |
| K193631 | Stethee Pro 1, Stethee Pro Software System | M3Dicine Pty , Ltd. | 2020-10-09 | 287 | 0 |
| K200862 | Feelix Stethoscope | Sonavi Labs, Inc. | 2020-09-14 | 166 | 0 |
| K201299 | HD Steth | Hd Medical, Inc. | 2020-07-10 | 56 | 0 |
| K200776 | Eko CORE | Eko Devices, Inc. | 2020-04-06 | 12 | 0 |
| K191667 | Electronic Stethoscope | Hefei Mintti Medical Technology Co., Ltd. China | 2019-12-18 | 180 | 0 |
| K183710 | Vivio System | Avicena, LLC | 2019-10-04 | 277 | 0 |
| K181988 | eMurmur ID | Csd Labs GmbH | 2019-04-17 | 266 | 0 |
| K181882 | eKuore One electronic interface for stethoscope | Chip Ideas Electronics S.L. | 2019-03-27 | 257 | 0 |
| K181612 | Tyto Stethoscope (OTC) | Tyto Care , Ltd. | 2018-12-17 | 181 | 0 |
| K182196 | Cardiart Electronic Stethoscope Model DS101 Omni-Steth Elect | Imediplus, Inc. | 2018-09-11 | 28 | 0 |
| K173663 | Electronic Stethoscope DS3011A | Imediplus, Inc. | 2018-08-17 | 261 | 0 |
| K173448 | CliniCloud Stethoscope | Stethocloud Pty.Ltd (Clinicloud) | 2018-01-25 | 80 | 0 |
| K172296 | Stethee Pro | M3Dicine Pty , Ltd. | 2017-10-30 | 91 | 0 |
| K170928 | CADence System | Aum Cardiovascular, Inc. | 2017-08-03 | 127 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda