The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- CanadaEPIPHANY CARDIO SERVER104894
Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.13 |
| 2019-02 | 0 | 1.7 |
| 2019-03 | 0 | 3.83 |
| 2019-04 | 0 | 2.7 |
| 2019-05 | 0 | 2 |
| 2019-06 | 0 | 3 |
| 2019-07 | 0 | 2.88 |
| 2019-08 | 0 | 2.33 |
| 2019-09 | 0 | 2.44 |
| 2019-10 | 0 | 3.36 |
| 2019-11 | 0 | 2.23 |
| 2019-12 | 0 | 2.67 |
| 2020-01 | 0 | 1.83 |
| 2020-02 | 0 | 2.46 |
| 2020-03 | 0 | 3.75 |
| 2020-04 | 0 | 2.4 |
| 2020-05 | 0 | 2.5 |
| 2020-06 | 0 | 1.91 |
| 2020-07 | 0 | 2.27 |
| 2020-08 | 0 | 2.62 |
| 2020-09 | 0 | 1.9 |
| 2020-10 | 0 | 2.5 |
| 2020-11 | 0 | 3.36 |
| 2020-12 | 0 | 2.7 |
| 2021-01 | 0 | 3.2 |
| 2021-02 | 0 | 2.9 |
| 2021-03 | 0 | 2.8 |
| 2021-04 | 1 | 3.38 |
| 2021-05 | 0 | 7.33 |
| 2021-06 | 0 | 2.91 |
| 2021-07 | 0 | 2.5 |
| 2021-08 | 0 | 5.1 |
| 2021-09 | 0 | 4.07 |
| 2021-10 | 0 | 2.59 |
| 2021-11 | 0 | 3.31 |
| 2021-12 | 0 | 4.33 |
| 2022-01 | 0 | 4.56 |
| 2022-02 | 0 | 4 |
| 2022-03 | 0 | 4.38 |
| 2022-04 | 0 | 4.11 |
| 2022-05 | 0 | 3.33 |
| 2022-06 | 0 | 2.94 |
| 2022-07 | 0 | 2.77 |
| 2022-08 | 0 | 2.29 |
| 2022-09 | 0 | 3.67 |
| 2022-10 | 0 | 3.25 |
| 2022-11 | 0 | 2.4 |
| 2022-12 | 0 | 3.54 |
| 2023-01 | 0 | 3.3 |
| 2023-02 | 0 | 3.76 |
| 2023-03 | 0 | 3.38 |
| 2023-04 | 0 | 3.2 |
| 2023-05 | 0 | 3.22 |
| 2023-06 | 0 | 3.85 |
| 2023-07 | 0 | 2.42 |
| 2023-08 | 0 | 2.6 |
| 2023-09 | 0 | 2.62 |
| 2023-10 | 0 | 2.39 |
| 2023-11 | 0 | 4.15 |
| 2023-12 | 0 | 8.23 |
| 2024-01 | 0 | 4.16 |
| 2024-02 | 0 | 5.55 |
| 2024-03 | 0 | 4.5 |
| 2024-04 | 0 | 5.75 |
| 2024-05 | 0 | 6.11 |
| 2024-06 | 0 | 7.11 |
| 2024-07 | 0 | 3 |
| 2024-08 | 0 | 4.38 |
| 2024-09 | 0 | 5.83 |
| 2024-10 | 0 | 3.56 |
| 2024-11 | 0 | 4.41 |
| 2024-12 | 0 | 2.79 |
| 2025-01 | 0 | 4.16 |
| 2025-02 | 0 | 3.33 |
| 2025-03 | 0 | 3.4 |
| 2025-04 | 0 | 3.6 |
| 2025-05 | 0 | 5.39 |
| 2025-06 | 0 | 1.78 |
| 2025-07 | 0 | 3 |
| 2025-08 | 0 | 2.63 |
| 2025-09 | 0 | 2.36 |
| 2025-10 | 0 | 2.42 |
| 2025-11 | 0 | 3.21 |
| 2025-12 | 0 | 2.65 |
| 2026-01 | 0 | 3.43 |
| 2026-02 | 0 | 3.65 |
| 2026-03 | 0 | 2.22 |
| 2026-04 | 0 | 2.5 |
| 2026-05 | 0 | 2.64 |
| 2026-06 | 0 | 2.26 |
No recalls linked.
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
None in the loaded window.
- 12 Pneumatic Endo probes for Endo PAT 2000 ITAMAR MEDICAL LTD
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