AeviceMD
Model Silicone Patch AE01 · AEVICE HEALTH PTE. LTD. · DI 08883000003064
DQD — Stethoscope, Electronic · Class II · 21 CFR 870.1875
DSH — Recorder, Magnetic Tape, Medical · Class II · 21 CFR 870.2800
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 8 |
| 2019-02 | 0 | 2.5 |
| 2019-03 | 0 | 22 |
| 2019-04 | 0 | 16 |
| 2019-05 | 0 | 12 |
| 2019-06 | 0 | 17 |
| 2019-07 | 0 | 8 |
| 2019-08 | 0 | 7 |
| 2019-09 | 0 | 7.67 |
| 2019-10 | 0 | 5 |
| 2019-11 | 0 | 4 |
| 2019-12 | 0 | 4.5 |
| 2020-01 | 0 | 31 |
| 2020-02 | 0 | 21 |
| 2020-03 | 0 | 15 |
| 2020-04 | 0 | 12 |
| 2020-05 | 0 | 6 |
| 2020-06 | 0 | 10.5 |
| 2020-07 | 0 | 21 |
| 2020-08 | 0 | 11 |
| 2020-09 | 0 | 33 |
| 2020-10 | 0 | 13.5 |
| 2020-11 | 0 | 22 |
| 2020-12 | 0 | 33 |
| 2021-01 | 0 | 9 |
| 2021-02 | 0 | 10 |
| 2021-03 | 0 | 22 |
| 2021-04 | 0 | 16 |
| 2021-05 | 0 | 30 |
| 2021-06 | 0 | 33 |
| 2021-07 | 0 | 16.5 |
| 2021-08 | 0 | 24 |
| 2021-09 | 0 | 5.5 |
| 2021-10 | 0 | 3 |
| 2021-11 | 0 | 3.5 |
| 2021-12 | 0 | 5.5 |
| 2022-01 | 0 | 5 |
| 2022-02 | 0 | 8.5 |
| 2022-03 | 0 | 7 |
| 2022-04 | 0 | 2.5 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 1.5 |
| 2022-09 | 0 | 2.5 |
| 2023-04 | 0 | 1 |
| 2023-06 | 0 | 2 |
| 2023-07 | 0 | 1 |
| 2023-10 | 0 | 1.75 |
| 2023-11 | 0 | 8.5 |
| 2023-12 | 0 | 17.25 |
| 2024-01 | 0 | 12.25 |
| 2024-02 | 0 | 16.67 |
| 2024-03 | 0 | 13.5 |
| 2024-04 | 0 | 28.5 |
| 2024-05 | 0 | 22 |
| 2024-06 | 0 | 32.33 |
| 2024-07 | 0 | 4.67 |
| 2024-08 | 0 | 7.75 |
| 2024-09 | 0 | 4.5 |
| 2024-10 | 0 | 9 |
| 2024-11 | 0 | 4.8 |
| 2024-12 | 0 | 4.2 |
| 2025-01 | 0 | 8.5 |
| 2025-02 | 0 | 7.67 |
| 2025-03 | 0 | 8.67 |
| 2025-04 | 0 | 13 |
| 2025-05 | 0 | 14 |
| 2025-06 | 0 | 9.67 |
| 2025-07 | 0 | 11.67 |
| 2025-08 | 0 | 9.83 |
| 2025-09 | 0 | 13 |
| 2025-10 | 0 | 6.6 |
| 2025-11 | 0 | 24 |
| 2025-12 | 0 | 19 |
| 2026-01 | 0 | 19.67 |
| 2026-02 | 0 | 40 |
| 2026-03 | 0 | 28.5 |
| 2026-04 | 0 | 40 |
| 2026-05 | 0 | 10.75 |
| 2026-06 | 0 | 3 |
Regulatory clearances
- K243603 SESE 2025-05-05 (k number procode)
- K223382 SESE 2023-07-07 (k number procode)
Predicate lineage
K223382 — cites (transitively): K200776 (d1), K220893 (d1), K151319 (d2), K181612 (d2), K201077 (d2), K083903 (d3), K102893 (d3), K160401 (d3), K173448 (d3), K110525 (d3), K072026 (d4), K101022 (d4), K050159 (d4), K071955 (d5) — cited as predicate by K243603
K243603 — cites (transitively): K200776 (d1), K223382 (d1), K151319 (d2), K181612 (d2), K220893 (d2), K083903 (d3), K102893 (d3), K160401 (d3), K173448 (d3), K201077 (d3), K072026 (d4), K050159 (d4), K110525 (d4), K101022 (d5), K071955 (d6)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — AEVICE HEALTH PTE. LTD.
Nothing in the loaded window.