510(k) · Cleared
ClearedAeviceMD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aevice Health Pte., Ltd. · DSH Recorder, Magnetic Tape, Medical
Cleared on May 5, 2025 as substantially equivalent to K223382 (Aevice Health Pte., Ltd., 2023) after a 165-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- May 5, 2025
- Review
- 165 days
- Class
- Class II
- Product code
- DSH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K943862 (1995). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- 5 generations between
- 3 generations backK201077 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020
- 2 generations backK220893 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022
- 1 generation backK223382 AeviceMDAevice Health Pte., Ltd. · 2023
- This deviceK243603 AeviceMDAevice Health Pte., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK943862 Sonicaid Model MR-63 Ambulatory Ecg RecorderOxford Instruments Medical Systems · 1995
- 8 generations backK970902 Medilog FD4Oxford Instruments Medical Systems · 1997
- 7 generations backK070818 MEDILOGAR4, MEDILOGAR12Tom Medical Entwicklungs GmbH · 2007
- 6 generations backK083820 Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model…Vasomedical, Inc. · 2009
- 5 generations backK101022 Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
- 4 generations backK110525 Vitalograph Model 7100 - VitalojakVitalograph (Ireland), Ltd. · 2011
- 3 generations backK201077 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs · 2020
- 2 generations backK220893 Strados Remote Electronic Stethoscope Platform (RESP)Strados Labs, Inc. · 2022
- 1 generation backK223382 AeviceMDAevice Health Pte., Ltd. · 2023
- This deviceK243603 AeviceMDAevice Health Pte., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943862 | Sonicaid Model MR-63 Ambulatory Ecg Recorder | Oxford Instruments Medical Systems | 1995 | — |
| −8 | K970902 | Medilog FD4 | Oxford Instruments Medical Systems | 1997 | — |
| −7 | K070818 | MEDILOGAR4, MEDILOGAR12 | Tom Medical Entwicklungs GmbH | 2007 | — |
| −6 | K083820 | Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C | Vasomedical, Inc. | 2009 | — |
| −5 | K101022 | Pulmotrack 5050 Wholter, Model 5050 | Karmelsonix | 2010 | — |
| −4 | K110525 | Vitalograph Model 7100 - Vitalojak | Vitalograph (Ireland), Ltd. | 2011 | — |
| −3 | K201077 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs | 2020 | — |
| −2 | K220893 | Strados Remote Electronic Stethoscope Platform (RESP) | Strados Labs, Inc. | 2022 | — |
| −1 | K223382 | AeviceMD | Aevice Health Pte., Ltd. | 2023 | — |
| 0 (this device) | K243603 | AeviceMD | Aevice Health Pte., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
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 DSH? 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 DSH device
- #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 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 |
|---|---|---|---|
| * | K223382 | AeviceMDSummary page 5…lassification Code: DSH; DQD III. PREDICATE AND REFERENCE DEVICES Predicate Manufacturer: AeviceMD Predicate Trade Name: Aevice Health Pte. Ltd. Predicate 510(k): K223382 Reference Device Manufacturer: Eko Devices, Inc. Reference Device Trade Name: Eko CORE Reference Device 510(k): K200776… | 2023 |
| † | K200776 | Eko CORE | 2020 |
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?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All DSH devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSH
No recall names DSH since 2007.
Adverse event reports per year · DSH
213in 2025
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients (aged 3 years and above) in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243603: AeviceMD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243603
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026